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Dental Ceramic
EUDAMEDClass IIa (EU MDR)
Ref 06936536115113Model Metal Ceramic, Zirconia Ceramic, and associated accessory (Formative Liquid)
Identity
- Trade Name
- Dental Ceramic EUDAMED
- Device Name
- Dental Ceramic EUDAMED
- Model / Reference
- Metal Ceramic, Zirconia Ceramic, and associated accessory (Formative Liquid) EUDAMED06936536115113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936536115113 EUDAMED
- Basic UDI-DI
- 697313331CE01BG EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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 Ceramic by BAOT Biological Technology Co., Ltd. — Class IIa — 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 | 697313331CE01BG | Class IIa | Active |
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Manufacturer
- Manufacturer
- BAOT Biological Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017164
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f31dbee4-5a64-494a-adf4-a87e2121303c 61 fields · synced Jul 21, 2026