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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

Giraffe Warmer

M1118179

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682103923
Basic UDI-DI: 08406821BUG0051474
Reference: M1118179
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 05:02

Manufacturer products Authorised representative products Authorised representative actors View details

Panda Freestanding Warmer

2063568-001

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682103916
Basic UDI-DI: 08406821BUG0051576
Reference: 2063568-001
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 05:02

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Panda Wall Mount Warmer

2063570-001

Class IIbMDR 2017/745On the marketDirect marking

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000002206
UDI-DI: 00840682103909
Basic UDI-DI: 08406821BUG0051678
Reference: 2063570-001
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 05:02

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

Sonata Dispersive Electrode

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle use

Manufacturer: Gynesonics, Inc.
Manufacturer SRN: US-MF-000017044
UDI-DI: 10817929020364
Basic UDI-DI: 081792902RFDEEB
Reference: DE-001
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

Sonata® Transcervical Fibroid Ablation System

SONATA2-220

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Gynesonics, Inc.
Manufacturer SRN: US-MF-000017044
UDI-DI: 10817929020333
Basic UDI-DI: 081792902SONATAKA
Reference: SONATA2-220
EMDN: Z12080299
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 04:34

Manufacturer products Authorised representative products Authorised representative actors View details

Sonata IUUS Probe Return Kit

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Gynesonics, Inc.
Manufacturer SRN: US-MF-000017044
UDI-DI: 10817929020036
Basic UDI-DI: 081792902RTNKITNB
Reference: RTN-001
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

traxi Panniculus Retractor Eval Kit

PRS-0530

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Clinical Innovations, LLC
Manufacturer SRN: US-MF-000031386
UDI-DI: 00814247020802
Basic UDI-DI: 0814247001030QV
Reference: PRS-EVAL
EMDN: Z12080399
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: MVF
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section

VAC-6000ME

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Clinical Innovations, LLC
Manufacturer SRN: US-MF-000031386
UDI-DI: 00814247020628
Basic UDI-DI: 0814247006000RP
Reference: VAC-6000C
EMDN: Z12080301
EMDN description: OBSTETRIC VACUUM EXTRACTORS
First on market country: Italy
Authorised representative: MVF
Last updated: 16.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

ClearView Uterine Manipulator 7cm tip

UM700

Class IIaMDR 2017/745On the marketCMR substanceMeasuring functionSingle useSterile

Manufacturer: Clinical Innovations, LLC
Manufacturer SRN: US-MF-000031386
UDI-DI: 00814247020017
Basic UDI-DI: 0814247700900UM
Reference: UM700
EMDN: Z120899
EMDN description: GYNAECOLOGY AND MATERNAL-INFANTS INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: MVF
Last updated: 16.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

10812432022485

Disposables Pad Covers and Pad Nests Product Family

Class IMDR 2017/745On the marketSingle use

Manufacturer: Lumitex Medical Devices, Inc.
Manufacturer SRN: US-MF-000030520
UDI-DI: 10812432022485
Basic UDI-DI: 081243202MD078QM
Reference: 2105423-001
EMDN: Z12080499
EMDN description: NEONATOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details