Identity
- Trade Name
- Revamil Tulle 8x8 per 5 EUDAMED
- Device Name
- PureHoney EUDAMED
- Model / Reference
- 10318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717438011080 EUDAMED
- Basic UDI-DI
- 08717438PureHoneyST EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Revamil Tulle 8x8 per 5 by Bfactory Health Products B.V. — Class IIb — 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 | 08717438PureHoneyST | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bfactory Health Products B.V.
- EUDAMED SRN
- NL-MF-000021590
Sources (1)
- EUDAMED ace2f9b9-d568-4b5c-820a-e01f5c77d11c 61 fields · synced Jul 24, 2026