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Wingman
EUDAMEDClass IIa (EU MDR)
Ref WGM35135CEModel WGM, WMC, SPX, SPN, SLPRef WMC14090CERef WGM18135CERef WGM18090CERef WGM35065CE
Identity
- Trade Name
- Wingman EUDAMED
- Model / Reference
- WGM, WMC, SPX, SPN, SLP EUDAMEDWGM35135CE EUDAMEDWMC14090CE EUDAMEDWGM18135CE EUDAMEDWGM18090CE EUDAMEDWGM35065CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00856492005029 EUDAMED00856492005487 EUDAMED00856492005210 EUDAMED00856492005203 EUDAMED00856492005005 EUDAMED
- Basic UDI-DI
- 856492005SupportCathKP EUDAMED
- EMDN Code
- C0104020209 PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wingman by Reflow Medical, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 856492005SupportCathKP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Reflow Medical, Inc.
- EUDAMED SRN
- US-MF-000017521
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (5)
- EUDAMED a6610540-78a4-43df-b765-e5ab60622da6 61 fields · synced Oct 6, 2026
- EUDAMED 5d7b8a86-6d25-4cd8-9fdc-35bce7b56ef8 61 fields · synced May 17, 2026
- EUDAMED db1c12b5-e54e-4170-9399-b4761fbb3db2 61 fields · synced May 17, 2026
- EUDAMED e6cfcfc6-b5d7-4da9-936e-47b29d77b8fb 61 fields · synced May 17, 2026
- EUDAMED fb55485d-1425-46d9-9052-dccf7fff82ff 61 fields · synced May 18, 2026