Identity
- Device Name
- Dental Film EUDAMED
- Model / Reference
- UreMega011 076125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978386220012 EUDAMED
- Basic UDI-DI
- 697838622DF5T EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Dental Film by Shanghai Uretech Film Materials 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 | 697838622DF5T | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Uretech Film Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000046804
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 1b445bd7-2e34-4608-9724-a6c53b0ea435 61 fields · synced Jul 13, 2026