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229 device results listed.

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Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: A.M.I. Agency for Medical Innovations GmbH
Manufacturer SRN: AT-MF-000016792
UDI-DI: +EAMIICT50110
Basic UDI-DI: ++EAMIA47B4C1D2NR
Reference: ICT5011
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.07.2026 00:43

Manufacturer products View details

Opal

OPAL H1

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Inti Taiwan, Inc.
Manufacturer SRN: TW-MF-000048831
UDI-DI: 04719961300048
Basic UDI-DI: 471996130OPALHK4
Reference: Opal H2
EMDN: Z12080202
EMDN description: OOCYTE ASPIRATION EQUIPMENT
First on market country: Spain
Authorised representative: Luana Med. B.V.
Last updated: 16.07.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

Danae App

Class IMDR 2017/745On the marketActive device

Manufacturer: Danae Netherlands BV
Manufacturer SRN: NL-MF-000048363
UDI-DI: 08720892749406
Basic UDI-DI: 08720892App-06-V1.0PE
Reference: Danae App 2025-06
EMDN: Z12080282
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 07:05

Manufacturer products View details

Embryo Predict

200-00201

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Alife Health Inc.
Manufacturer SRN: US-MF-000028240
UDI-DI: 00860008987204
Basic UDI-DI: 08600089872HERARB
Reference: 200-00201
EMDN: Z12080292
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Double Valve Aspirator

DOUBLE-VALVE ASPIRATOR

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 10853615006366
Basic UDI-DI: 0853615006DVSSTERILELH
Reference: DVS-S10
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Single Valve Aspirator

SINGLE-VALVE ASPIRATOR

Class IMDR 2017/745On the marketSterile

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 10853615006359
Basic UDI-DI: 0853615006SVSSTERILE27
Reference: SVS-S10
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Denniston Dilators

DENNISTON DILATORS

Class IMDR 2017/745On the marketSterile

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006376
Basic UDI-DI: 0853615006DILATORSPC
Reference: DD5-S
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

6mm Adapter

ADAPTER SET

Class IMDR 2017/745On the market

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006338
Basic UDI-DI: 0853615006ADAPTER5B
Reference: ADP-6MM
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Miscarriage Management Kit

MISCARRIAGE MANAGEMENT KIT

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006291
Basic UDI-DI: 0853615006MMK5E
Reference: MMK-SU
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

3mm Cannula

3MM CANNULAE

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006284
Basic UDI-DI: 08536150063MMZJ
Reference: EB3
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Single Valve Aspirator

SINGLE-VALVE ASPIRATOR

Class IMDR 2017/745On the market

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006277
Basic UDI-DI: 0853615006SVSNONSTERILESS
Reference: SVS-LF
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Ipas MVA Plus® Aspirator

IPAS MVA PLUS® ASPIRATOR

Class IMDR 2017/745On the market

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006260
Basic UDI-DI: 0853615006IPASMVAPLUS8K
Reference: PLUS
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Double Valve Aspirator, unsterile

DOUBLE-VALVE ASPIRATOR

Class IMDR 2017/745On the marketSingle use

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006253
Basic UDI-DI: 0853615006DVSNONSTERILE7K
Reference: DVS-SU
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Ipas EasyGrip® Cannula, size 10mm

IPAS EASYGRIP® CANNULA

Class IMDR 2017/745On the marketSterile

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006093
Basic UDI-DI: 0853615006EASYGRIPTD
Reference: SR10
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Flexible Karman Cannula, size 10mm

FLEXIBLE KARMAN CANNULA

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: WomanCare Global, LLC
Manufacturer SRN: US-MF-000042625
UDI-DI: 00853615006000
Basic UDI-DI: 0853615006FLEXIBLERB
Reference: FC10
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Donawa Lifescience Consulting Srl
Last updated: 16.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

Exhaust Collection Bag

Class IMDR 2017/745On the marketSingle use

Manufacturer: Channel Medsystems, Inc.
Manufacturer SRN: US-MF-000028229
UDI-DI: 00850008595042
Basic UDI-DI: 0850008595ECBZF
Reference: FGS-7015
EMDN: Z12080201
EMDN description: ENDOMETRIAL ABLATION EQUIPMENT
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 06:09

Manufacturer products Authorised representative products Authorised representative actors View details

Cerene Cryotherapy Device

FGS-7000

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Channel Medsystems, Inc.
Manufacturer SRN: US-MF-000028229
UDI-DI: 00850008595035
Basic UDI-DI: 0850008595CCDZ9
Reference: FGS-7000
EMDN: Z12080201
EMDN description: ENDOMETRIAL ABLATION EQUIPMENT
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 06:09

Manufacturer products Authorised representative products Authorised representative actors View details

Sonata RFA Cable, reusable

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Gynesonics, Inc.
Manufacturer SRN: US-MF-000017044
UDI-DI: 30817929020177
Basic UDI-DI: 081792902RFACBLC9
Reference: ACCY-008
EMDN: Z12080280
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 04:35

Manufacturer products Authorised representative products Authorised representative actors View details

Sonata IUUS Probe Connector Protector

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Gynesonics, Inc.
Manufacturer SRN: US-MF-000017044
UDI-DI: 10817929020463
Basic UDI-DI: 081792902IUSPCCK9
Reference: ACCY-018
EMDN: Z12080280
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 04:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sonata Radiofrequency Ablation Handpiece

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Gynesonics, Inc.
Manufacturer SRN: US-MF-000017044
UDI-DI: 10817929020371
Basic UDI-DI: 081792902RFAHPD5
Reference: RFA-002
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 04:34

Manufacturer products Authorised representative products Authorised representative actors View details