Identity
- Trade Name
- Cover 60g EUDAMED
- Device Name
- ShieldCover EUDAMED
- Model / Reference
- 11040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717438010083 EUDAMED
- Basic UDI-DI
- 08717438ShieldCover7U EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Cover 60g by Bfactory Health Products B.V. — Class I — 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 | 08717438ShieldCover7U | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bfactory Health Products B.V.
- EUDAMED SRN
- NL-MF-000021590
Sources (1)
- EUDAMED cdc427d5-87e6-446e-89fe-c01bd55d9dcd 61 fields · synced Jun 19, 2026