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Q01010199
EUDAMEDClass IIa (EU MDR)
Ref 06936536121107Model Metal Ceramic, Zirconia Ceramic, and associated accessory (Formative Liquid)
Identity
- Trade Name
- Q01010199 EUDAMED
- Device Name
- Dental Ceramic EUDAMED
- Model / Reference
- Metal Ceramic, Zirconia Ceramic, and associated accessory (Formative Liquid) EUDAMED06936536121107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936536121107 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
Category: Dental appliance fabrication material, ceramic
Q01010199 by BAOT Biological Technology Co., Ltd. — Class IIa — 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 | 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 441019b4-5a6f-48e5-ade1-f8e171c2fa2c 61 fields · synced Jul 14, 2026