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04719894432434

Disposable Cervical Dilator

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Bioteque Taiwan Ltd.
Manufacturer SRN: TW-MF-000043818
UDI-DI: 04719894432434
Basic UDI-DI: 47198944304019Z
Reference: OS265BA-1
EMDN: U0899
EMDN description: GYNAECOLOGICAL DEVICES - OTHER
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:52

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Preferred Curette

Endometrial Sampling Curettes

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Bioteque Taiwan Ltd.
Manufacturer SRN: TW-MF-000043818
UDI-DI: 04719894432311
Basic UDI-DI: 47198944302009M
Reference: M0014
EMDN: U089010
EMDN description: UTERINE CURETTES, SINGLE-USE
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:52

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Supersoft

Silicone External Catheter

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dileh Medical supplies co., Ltd.
Manufacturer SRN: TW-MF-000016927
UDI-DI: 04716820130280
Basic UDI-DI: 471682013693410HW
Reference: 30013
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 31.07.2026 06:42

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Supersoft

Silicone External Catheter

Class IMDR 2017/745On the marketReprocessedSingle use

Manufacturer: Dileh Medical supplies co., Ltd.
Manufacturer SRN: TW-MF-000016927
UDI-DI: 04716820130235
Basic UDI-DI: 471682013693410HW
Reference: 30006
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 31.07.2026 06:33

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Transvaginal Access Port

TRV Series

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Lagis Enterprise Co., Ltd.
Manufacturer SRN: TW-MF-000007081
UDI-DI: 04714123029010
Basic UDI-DI: 471412302TRV-014A
Reference: TRV-0310R
EMDN: U0899
EMDN description: GYNAECOLOGICAL DEVICES - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:32

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EosSpec I

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: NORTH EOS INDUSTRIES,INC.
Manufacturer SRN: TW-MF-000007743
UDI-DI: 04712568360019
Basic UDI-DI: 471256836GYNLU
Reference: EosSpec I-L
EMDN: U089006
EMDN description: VAGINAL SPECULUM, SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 06:28

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Catheter Spigot

1820-0000

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04711182605612
Basic UDI-DI: 4710961930201010199
Reference: 1820-0000
EMDN: U0280
EMDN description: URETERAL CATHETERS AND STENTS - ACCESSORIES
First on market country: Bulgaria
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:27

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04710970381400

LAWD1102 LAWD1103

Class IMDR 2017/745On the market

Manufacturer: R&R Medical Corporation Ltd.
Manufacturer SRN: TW-MF-000029155
UDI-DI: 04710970381400
Basic UDI-DI: 471097038LPD019A
Reference: LAWD1102
EMDN: U0899
EMDN description: GYNAECOLOGICAL DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 06:27

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MTK-1MD

Micromanipulator 02

Class IMDR 2017/745On the market

Manufacturer: Narishige Lifemed Co., Ltd.
Manufacturer SRN: JP-MF-000033180
UDI-DI: 04589818020340
Basic UDI-DI: 458981802MnpSy02Y3
Reference: 034
EMDN: U08020399
EMDN description: DEVICES FOR MICROMANIPULATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION - OTHER
First on market country: Netherlands
Authorised representative: Narishige International Limited
Last updated: 31.07.2026 06:18

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Cryotec

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: REPROLIFE Inc.
Manufacturer SRN: JP-MF-000031415
UDI-DI: 04589700011012
Basic UDI-DI: 458970001TECND
Reference: TEC 010B
EMDN: U08020401
EMDN description: CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION
First on market country: Denmark
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 06:18

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Dry Incubator / EC6S-230MR

EC6S-230MR

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ASTEC CO.,Ltd
Manufacturer SRN: JP-MF-000020597
UDI-DI: 04580647510040
Basic UDI-DI: 458064751A001IY8
Reference: EC6S-230MR
EMDN: U080299
EMDN description: DEVICES FOR ASSISTED REPRODUCTION - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:15

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Embryo Grid / AID-0125M

AID-0125M

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ASTEC CO.,Ltd
Manufacturer SRN: JP-MF-000020597
UDI-DI: 04580647510033
Basic UDI-DI: 458064751A002DXZ
Reference: AID-0125M
EMDN: U080206
EMDN description: CULTURE PLATES FOR ASSISTED REPRODUCTION
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:15

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04580303266656

IUI Catheter

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Kitazato Corporation
Manufacturer SRN: JP-MF-000018374
UDI-DI: 04580303266656
Basic UDI-DI: 458223146IUIJZ
Reference: 131181
EMDN: U08020101
EMDN description: CATHETERS FOR INSEMINATION
First on market country: Spain
Authorised representative: BIOMEDICAL SUPPLY, S.L.
Last updated: 31.07.2026 06:14

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04580303266083

ET Catheter

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Kitazato Corporation
Manufacturer SRN: JP-MF-000018374
UDI-DI: 04580303266083
Basic UDI-DI: 458223146ETCHW
Reference: 213322
EMDN: U08020102
EMDN description: CATHETERS FOR EMBRYO TRANSFER
First on market country: Spain
Authorised representative: BIOMEDICAL SUPPLY, S.L.
Last updated: 31.07.2026 06:14

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04580303260906

Kitazato OPU Needle

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Kitazato Corporation
Manufacturer SRN: JP-MF-000018374
UDI-DI: 04580303260906
Basic UDI-DI: 458223146OPUL8
Reference: 347275
EMDN: U08020201
EMDN description: SINGLE LUMEN NEEDLES AND SETS/SYSTEMS FOR OOCYTE RETRIEVAL
First on market country: Spain
Authorised representative: BIOMEDICAL SUPPLY, S.L.
Last updated: 31.07.2026 06:14

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04573316385872

Cryotop®

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Kitazato Corporation
Manufacturer SRN: JP-MF-000018374
UDI-DI: 04573316385872
Basic UDI-DI: 458223146CRYJS
Reference: 81225
EMDN: U08020401
EMDN description: CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION
First on market country: Spain
Authorised representative: BIOMEDICAL SUPPLY, S.L.
Last updated: 31.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

PURE CATH

Self-Catheterization Set

Class IMDR 2017/745Not intended for EU market

Manufacturer: CREATE MEDIC CO., LTD.
Manufacturer SRN: JP-MF-000010849
UDI-DI: 04542187214062
Basic UDI-DI: 45421870001896
Reference: 800-000-9913
EMDN: U010199
EMDN description: URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

dres kegel

HNJ-1000

Class IMDR 2017/745On the marketActive device

Manufacturer: SmartMann GmbH
Manufacturer SRN: DE-MF-000049779
UDI-DI: 04262560510023
Basic UDI-DI: 426256HNJ-1000LQ
Reference: SMM-CA0508-2K504
EMDN: U070301
EMDN description: PELVIC FLOOR REHABILITATION DEVICES, BIOFEEDBACK, SINGLE-USE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:43

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dres kegel

HNJ-350K

Class IMDR 2017/745On the marketActive device

Manufacturer: SmartMann GmbH
Manufacturer SRN: DE-MF-000049779
UDI-DI: 04262560510030
Basic UDI-DI: 426256HNJ-350KPK
Reference: SMM-CA0507-1K504
EMDN: U070301
EMDN description: PELVIC FLOOR REHABILITATION DEVICES, BIOFEEDBACK, SINGLE-USE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:43

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PiezoXpert 4m

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BIOZOL Diagnostica Vertrieb GmbH
Manufacturer SRN: DE-MF-000043808
UDI-DI: 04262452791479
Basic UDI-DI: 426245279PiezoXpert7L
Reference: 5194000020
EMDN: U08020380
EMDN description: DEVICES FOR MICROMANIPULATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION - ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:37

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