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Bladder scanner

AS-1

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring functionReusable

Manufacturer: Avantsonic Technology Co.,LTD
Manufacturer SRN: CN-MF-000012322
UDI-DI: 06971759810001
Basic UDI-DI: 697175981000NH
Reference: Bladder scanner/AS-1
EMDN: Z12080304
EMDN description: ULTRASONIC BLADDER VOLUME SCANNERS
First on market country: France
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 12:15

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Fetal Doppler

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionReprocessedSingle use

Manufacturer: Vcomin Technology Limited
Manufacturer SRN: CN-MF-000039445
UDI-DI: (01)06970442094414
Basic UDI-DI: 697044209FDX8
Reference: FD-290B
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:20

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Fetal Doppler

IMAMI-50

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Unicare Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000032694
UDI-DI: 16951217631031
Basic UDI-DI: 69512176FDIMAMI50AK
Reference: RD-R-QP008-002/A/0
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:55

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Fetal Doppler

IMAMI-20

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Unicare Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000032694
UDI-DI: 16951217631017
Basic UDI-DI: 69512176FDIMAMI20AA
Reference: RD-R-QP008-002/A/0
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:55

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Fetal Doppler

IMAMI-30

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Unicare Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000032694
UDI-DI: 16951217631024
Basic UDI-DI: 69512176FDIMAMI30AD
Reference: RD-R-QP008-002/A/0
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:55

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Fetal Doppler

IMAMI-10

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Unicare Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000032694
UDI-DI: 16951217631000
Basic UDI-DI: 69512176FDIMAMI10A7
Reference: RD-R-QP008-002/A/0
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:55

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Doppler FHR Detector

500D+

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Bestman Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000031725
UDI-DI: 06937492645065
Basic UDI-DI: 69374926BF069374926000FL
Reference: /
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:14

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SRF618B6

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Guangzhou Sunray Medical Apparatus Co., Ltd.
Manufacturer SRN: CN-MF-000019807
UDI-DI: 06934667961357
Basic UDI-DI: 69346679SRF1001ZT
Reference: 069346679
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Sweden
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:58

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Fetal doppler

AD50A

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Hunan Accurate Bio-Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000012835
UDI-DI: 06927394500975
Basic UDI-DI: 69273945FD01SD
Reference: AD50D11
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:44

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NovaSure Impedance Controlled Endometrial Ablation System Advanced Disposable Device

NovaSure Impedance Controlled Endometrial Ablation System

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045508224
Basic UDI-DI: 54200455GSSNOVASURENSE6
Reference: NS2013
EMDN: Z12080201
EMDN description: ENDOMETRIAL ABLATION EQUIPMENT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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NovaSure Impedance Controlled Endometrial Ablation System RF Controller Model 10

NovaSure Impedance Controlled Endometrial Ablation System

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045508187
Basic UDI-DI: 54200455GSSNOVASURERFCSJ
Reference: RFC2010
EMDN: Z12080201
EMDN description: ENDOMETRIAL ABLATION EQUIPMENT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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MyoSure MANUAL Tissue Removal Device

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045507937
Basic UDI-DI: 54200455GSSMANUALTRDT8
Reference: 20-401ML
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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MyoSure Control Unit

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045505124
Basic UDI-DI: 54200455GSSMYOSURECTRL5B
Reference: 10-550
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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MyoSure REACH Tissue Removal Device

MyoSure REACH Tissue Removal Device; MyoSure LITE Tissue Removal Device; MyoSure XL Tissue Removal Device; MyoSure XL Tissue Removal Device for Fluent

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045504530
Basic UDI-DI: 54200455GSSMYOSURETRDQK
Reference: 10-401FC
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

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SONICAID

TEAM3A

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05051968032485
Basic UDI-DI: 5060693520389WY
Reference: TEAM3A
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Ireland
Authorised representative: -
Last updated: 02.07.2026 02:28

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SONICAID

ACC-OBS-021

Class IMDR 2017/745On the marketActive device

Manufacturer: ArjoHuntleigh AB
Manufacturer SRN: SE-MF-000000696
UDI-DI: 05051968030825
Basic UDI-DI: 5060693520457WQ
Reference: ACC-OBS-032
EMDN: Z12080199
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 02.07.2026 02:28

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INFANT-Guardian

Class IIaMDR 2017/745Not intended for EU marketActive device

Manufacturer: K2 Medical Systems
Manufacturer SRN: GB-MF-000019924
UDI-DI: 05060470380083
Basic UDI-DI: 506047038InfantGuardianX7
Reference: INFANT-Guardian
EMDN: Z12080392
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Picis Clinical Solutions, S.A.
Last updated: 02.07.2026 02:18

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K2 Fetal Wellbeing™

K2 Fetal Wellbeing

Class IMDR 2017/745Not intended for EU marketActive device

Manufacturer: K2 Medical Systems
Manufacturer SRN: GB-MF-000019924
UDI-DI: 05060470380045
Basic UDI-DI: 506047038FetalWellbeingNS
Reference: Fetal Wellbeing
EMDN: Z12080392
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Picis Clinical Solutions, S.A.
Last updated: 02.07.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

astraia neon

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NEXUS / ASTRAIA GmbH
Manufacturer SRN: DE-MF-000007042
UDI-DI: 04260748856000
Basic UDI-DI: 426074885astneonCL
Reference: 1.0.x
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:09

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astraia – software for women's health - obstetric and gynaecological database application

astraia – software for women's health

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: NEXUS / ASTRAIA GmbH
Manufacturer SRN: DE-MF-000007042
UDI-DI: 04260748850008
Basic UDI-DI: 426074885ASTRAIASC
Reference: 1.27.4
EMDN: Z12080192
EMDN description: PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:09

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