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Dental Impression and prosthetic components
EUDAMEDClass I (EU MDR)
Ref 069476003001501EU
Identity
- Trade Name
- Dental Impression and prosthetic components EUDAMED
- Device Name
- Dental Impression and prosthetic components EUDAMED
- Model / Reference
- 069476003001501EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947600314448 EUDAMED
- Basic UDI-DI
- 069476003001501EU EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Impression and prosthetic components by BIO CONCEPT 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 | 069476003001501EU | Class I | Active |
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Manufacturer
- Manufacturer
- Bio Concept Co., Ltd.
- EUDAMED SRN
- CN-MF-000019318
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d6a61e12-659a-4232-b72f-6383fc8e1f74 61 fields · synced Jun 19, 2026