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10812432022515

Class IMDR 2017/745On the marketSingle use

Manufacturer: Lumitex Medical Devices, Inc.
Manufacturer SRN: US-MF-000030520
UDI-DI: 10812432022515
Basic UDI-DI: 081243202MD078QM
Reference: 2105420-001
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 29.06.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Novii+ Interface

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00195278212313
Basic UDI-DI: 8406821BUG00458HX
Reference: 5514131
EMDN: Z1208010403
EMDN description: TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 29.06.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Giraffe Blue Spot PT Lite

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00195278265074
Basic UDI-DI: 8406821BUG00394HW
Reference: M1236303
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 29.06.2026 17:39

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MyoSure LITE Tissue Removal Device

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045505070
Basic UDI-DI: 54200455GSSMYOSURETRDQK
Reference: 30-401LITE
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

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MyoSure XL Tissue Removal Device

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045505094
Basic UDI-DI: 54200455GSSMYOSURETRDQK
Reference: 50-501XL
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

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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: 15420045507654
Basic UDI-DI: 54200455GSSMYOSURETRDQK
Reference: 50-601XL
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

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NovaSure Impedance Controlled Endometrial Ablation System V5 Disposable Device

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Hologic, Inc.
Manufacturer SRN: US-MF-000003310
UDI-DI: 15420045515154
Basic UDI-DI: 54200455GSSNOVASURENSE6
Reference: NSV5-001
EMDN: Z12080201
EMDN description: ENDOMETRIAL ABLATION EQUIPMENT
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Macroduct Advanced Strap Set, Qty 180

Class IMDR 2017/745On the market

Manufacturer: ELITechGroup Inc.
Manufacturer SRN: US-MF-000006942
UDI-DI: 03661540300356
Basic UDI-DI: 3661540MacroAdvStrpYS
Reference: SS-270
EMDN: Z12080408
EMDN description: SWEAT TEST STIMULATORS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 29.06.2026 07:23

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Macroduct Advanced

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: ELITechGroup Inc.
Manufacturer SRN: US-MF-000006942
UDI-DI: 03661540304347
Basic UDI-DI: 3661540MacroAdvInducerS5
Reference: Model 3710
EMDN: Z12080408
EMDN description: SWEAT TEST STIMULATORS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 29.06.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

FOLLISCAN

Class IIaNot specifiedOn the market

Manufacturer: MIM Fertility Sp. z o.o.
Manufacturer SRN: PL-MF-000030821
UDI-DI: 05905090198925
Basic UDI-DI: 59050901989folliclesRZ
Reference: FOLLISCAN 1.1
EMDN: Z12080292
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 29.06.2026 03:05

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Fetal Monitors

MCF-21K

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Unicare Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000032694
UDI-DI: 06951217621103
Basic UDI-DI: 69512176FMMCF21KW4
Reference: RD-R-QP008-002/A/0
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 09:39

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Fetal Monitor

MCF-21B

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Unicare Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000032694
UDI-DI: 06951217621073
Basic UDI-DI: 69512176FMMCF21BVJ
Reference: RD-R-QP008-002/A/0
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 09:39

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Monitors

MCF-21K

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Unicare Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000032694
UDI-DI: 06951217621042
Basic UDI-DI: 69512176FMMCF21KW4
Reference: RD-R-QP008-002/A/0
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 09:39

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Monitor

MCF-21B

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Unicare Electronic Co., Ltd.
Manufacturer SRN: CN-MF-000032694
UDI-DI: 06951217621011
Basic UDI-DI: 69512176FMMCF21BVJ
Reference: RD-R-QP008-002/A/0
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 09:39

Manufacturer products Authorised representative products Authorised representative actors View details

Flotteur (pour récupérateur de liquides 4000 ml

YSB-III

Class IIaMDR 2017/745On the marketActive deviceReusable

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000028791
UDI-DI: 06947014618996
Basic UDI-DI: 69470146DQ00419910LQ
Reference: GH00048
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

Tuyau d'aspiration

YSB-III

Class IIaMDR 2017/745On the marketActive deviceReusable

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000028791
UDI-DI: 06947014618644
Basic UDI-DI: 69470146DQ00419910LQ
Reference: N5925
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Collecteur de tissus 300 ml, avec tuyau d'aspiration (Stérile)

YSB-III

Class IIaMDR 2017/745On the marketActive deviceReusableSingle useSterile

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000028791
UDI-DI: 06947014618637
Basic UDI-DI: 69470146DQ00419910LQ
Reference: P10020202
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Lame de morcellateur

YSB-III

Class IIaMDR 2017/745On the marketActive deviceReusable

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000028791
UDI-DI: 06947014618620
Basic UDI-DI: 69470146DQ00419910LQ
Reference: N5912
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Pédale double

YSB-III

Class IIaMDR 2017/745On the marketActive deviceReusable

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000028791
UDI-DI: 06947014618613
Basic UDI-DI: 69470146DQ00419910LQ
Reference: P7054A
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Pédale simple

YSB-III

Class IIaMDR 2017/745On the marketActive deviceReusable

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000028791
UDI-DI: 06947014618606
Basic UDI-DI: 69470146DQ00419910LQ
Reference: N5921
EMDN: Z12080204
EMDN description: MORCELLATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details