<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07290111520037</udiDi>
    <basicUdiDi>B-07290111520037</basicUdiDi>
    <tradeName>HeraBEAT</tradeName>
    <deviceName>HeraBEAT</deviceName>
    <manufacturerName>HeraMED Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000026750</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PACHBT000EN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:52:20.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432098686</udiDi>
    <basicUdiDi>B-07045432098686</basicUdiDi>
    <tradeName>NeoBeat</tradeName>
    <deviceName>NeoBeat</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LGH-532-00033</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:57:03.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>07045432081527</udiDi>
    <basicUdiDi>B-07045432081527</basicUdiDi>
    <tradeName>NeoBeat Newborn Heart Rate Meter</tradeName>
    <deviceName>NeoBeat</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>532-00033</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:56:29.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973912940051</udiDi>
    <basicUdiDi>B-06973912940051</basicUdiDi>
    <tradeName>Dopplo</tradeName>
    <deviceName>Ultrasonic Doppler Fetal Heart Rate Detector</deviceName>
    <manufacturerName>Shenzhen IMDK Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024290</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM2T925502</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:46:56.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973912940020</udiDi>
    <basicUdiDi>B-06973912940020</basicUdiDi>
    <tradeName>Dopplo</tradeName>
    <deviceName>Ultrasonic Doppler Fetal Heart Rate Detector</deviceName>
    <manufacturerName>Shenzhen IMDK Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024290</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM2T925502</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:46:55.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040105411</udiDi>
    <basicUdiDi>69450401CONTEC10CA7</basicUdiDi>
    <tradeName>Pocket Fetal Doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONTEC10CL</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:57.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>(01)06970442094414</udiDi>
    <basicUdiDi>697044209FDX8</basicUdiDi>
    <tradeName>Fetal Doppler</tradeName>
    <deviceName>Fetal Doppler</deviceName>
    <manufacturerName>Vcomin Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000039445</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-290B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:20:32.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>16951217631031</udiDi>
    <basicUdiDi>69512176FDIMAMI50AK</basicUdiDi>
    <tradeName>Fetal Doppler</tradeName>
    <deviceName>Fetal Doppler</deviceName>
    <manufacturerName>Shenzhen Unicare Electronic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032694</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-R-QP008-002/A/0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:55:51.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>16951217631017</udiDi>
    <basicUdiDi>69512176FDIMAMI20AA</basicUdiDi>
    <tradeName>Fetal Doppler</tradeName>
    <deviceName>Fetal Doppler</deviceName>
    <manufacturerName>Shenzhen Unicare Electronic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032694</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-R-QP008-002/A/0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:55:49.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>16951217631024</udiDi>
    <basicUdiDi>69512176FDIMAMI30AD</basicUdiDi>
    <tradeName>Fetal Doppler</tradeName>
    <deviceName>Fetal Doppler</deviceName>
    <manufacturerName>Shenzhen Unicare Electronic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032694</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-R-QP008-002/A/0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:55:47.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>16951217631000</udiDi>
    <basicUdiDi>69512176FDIMAMI10A7</basicUdiDi>
    <tradeName>Fetal Doppler</tradeName>
    <deviceName>Fetal Doppler</deviceName>
    <manufacturerName>Shenzhen Unicare Electronic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032694</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-R-QP008-002/A/0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:55:45.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937492645065</udiDi>
    <basicUdiDi>69374926BF069374926000FL</basicUdiDi>
    <tradeName>Doppler FHR Detector</tradeName>
    <deviceName>Ultrasound Series Doppler FHR Detectors</deviceName>
    <manufacturerName>Shenzhen Bestman Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031725</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:14:45.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927394500975</udiDi>
    <basicUdiDi>69273945FD01SD</basicUdiDi>
    <tradeName>Fetal doppler</tradeName>
    <deviceName>Fetal Doppler</deviceName>
    <manufacturerName>Hunan Accurate Bio-Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012835</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD50D11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:44:40.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413817289</udiDi>
    <basicUdiDi>69444138SD2SU4</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD2 Lite</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:21:02.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413817272</udiDi>
    <basicUdiDi>69444138SD2SU4</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD2 Basic</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:21:00.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413817265</udiDi>
    <basicUdiDi>69444138SD2SU4</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD2 Plus</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:20:59.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413817258</udiDi>
    <basicUdiDi>69444138SD2SU4</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD2 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:20:52.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413817241</udiDi>
    <basicUdiDi>69444138SD2SU4</basicUdiDi>
    <tradeName>06944413817241</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:20:51.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413808768</udiDi>
    <basicUdiDi>69444138SD12Z</basicUdiDi>
    <tradeName>06944413808768</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:06:47.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413801813</udiDi>
    <basicUdiDi>69444138SD3SU7</basicUdiDi>
    <tradeName>Ultrasonic Pocket Doppler</tradeName>
    <deviceName>Ultrasonic Pocket Doppler</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD3 PRO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:46:42.245Z</lastUpdated>
  </row>
</eudamedExport>