Identity
- Trade Name
- BARRIER FILM EUDAMED
- Device Name
- BARRIER FILM EUDAMED
- Model / Reference
- 4“x6" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975652007810 EUDAMED06978502823158 EUDAMED06978502823196 EUDAMED
- Basic UDI-DI
- 697565200BSF001EJ EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Barrier Film by Hubei Guarddent Medical Technology Co., Ltd — 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 | 697565200BSF001EJ | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Guarddent Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028116
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 37159735-47fe-4d2d-be5c-6b557b75bd46 61 fields · synced Oct 7, 2026
- EUDAMED 77170b17-36ab-4c9a-9da7-f48e7594a71b 61 fields · synced May 17, 2026
- EUDAMED 6d776699-b556-45f4-a8cc-bf193ed73e8b 61 fields · synced May 19, 2026