Identity
- Device Name
- Foam Dressing EUDAMED
- Model / Reference
- FD150150U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06940610126759 EUDAMED
- Basic UDI-DI
- 69406101FD00012P EUDAMED
- Unit of Use DI
- 06940610126742 EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Foam Dressing by Huizhou Foryou Medical Devices Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69406101FD00012P | Class IIb | Active |
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Manufacturer
- Manufacturer
- Huizhou Foryou Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007344
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED df4832f9-925d-4376-b488-39272a55153b 61 fields · synced Jun 19, 2026