Identity
- Trade Name
- Dental Implantation Instruments EUDAMED
- Device Name
- Dental Implantation Instruments EUDAMED
- Model / Reference
- 069476003001101E8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947600319900 EUDAMED
- Basic UDI-DI
- 069476003001101E8 EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER 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 Implantation Instruments 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 | 069476003001101E8 | 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 1f1193cb-9216-4694-af36-80d930a30d97 61 fields · synced Jun 18, 2026