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Fixed Dental Prosthesis
EUDAMEDClass I (EU MDR)
Ref 001Model PFM, Zirconia, Emax
Identity
- Trade Name
- Fixed Dental Prosthesis EUDAMED
- Device Name
- Fixed Dental Prosthesis EUDAMED
- Model / Reference
- PFM, Zirconia, Emax EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979379470018 EUDAMED
- Basic UDI-DI
- 697937947PFM001XX EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - 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
Category: Dental appliance fabrication material, ceramic
Fixed Dental Prosthesis by Meta Dental Technology Co Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697937947PFM001XX | Class I | Active |
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Manufacturer
- Manufacturer
- Meta Dental Technology Co Ltd
- EUDAMED SRN
- CN-MF-000050711
- Authorised Representative
- GRZAN GROUP SL ES-AR-000039086
Sources (1)
- EUDAMED eb3e9bca-c0d9-4477-980a-9be5fe3a7684 61 fields · synced Aug 4, 2026