Identity
- Trade Name
- BCBK01 EUDAMED
- Device Name
- BCBK01 EUDAMED
- Model / Reference
- 100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G5481000 EUDAMED
- Basic UDI-DI
- ++G548BCBK01ST EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Bcbk01 by Prilanta Surgical — 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 | ++G548BCBK01ST | Class I | Active |
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Manufacturer
- Manufacturer
- Prilanta Surgical
- EUDAMED SRN
- PK-MF-000038228
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 99ba5b80-56f3-424c-9ac4-a08d6d525381 61 fields · synced Jun 18, 2026