Identity
- Trade Name
- Frame EUDAMED
- Device Name
- Frame EUDAMED
- Model / Reference
- RD07,RD08 EUDAMEDRD08 EUDAMEDRD13S EUDAMEDRD07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454003947 EUDAMED06954454011768 EUDAMED06954454003930 EUDAMED
- Basic UDI-DI
- 69544540DDFR001KD EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Frame by Huanghua Promisee Dental 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 | 69544540DDFR001KD | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED ae963059-87c5-427a-993a-4348f4e2917d 61 fields · synced Oct 6, 2026
- EUDAMED 8263cba3-c55d-4d1f-8274-3979c8d33d92 61 fields · synced May 18, 2026
- EUDAMED 530ca03f-b5d5-4f46-b3d6-44b42b81719c 61 fields · synced May 18, 2026