Identity
- Trade Name
- Revamil Wound Dressing 8x8 per 5 EUDAMED
- Device Name
- PureHoney EUDAMED
- Model / Reference
- 10297 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717438011585 EUDAMED
- Basic UDI-DI
- 08717438PureHoneyST EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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: Scar-management dressing, reusable
Revamil Wound Dressing 8x8 per 5 by Bfactory Health Products B.V. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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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 | 08717438PureHoneyST | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bfactory Health Products B.V.
- EUDAMED SRN
- NL-MF-000021590
Sources (1)
- EUDAMED 9a6697a7-17d8-46b1-a0ff-6cdbd9fa02fa 61 fields · synced Jul 17, 2026