Identity
- Trade Name
- CERAMIC INSERT (BIOLOX ® DELTA), D36/48G EUDAMED
- Device Name
- CERAMIC INSERT (BIOLOX ® DELTA), D36/48G EUDAMED
- Model / Reference
- 380012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602248048 EUDAMED
- Basic UDI-DI
- B-08592602248048 EUDAMED
- EMDN Code
- P0908030402 HIP PROSTHESES CERAMIC ACETABULAR INSERTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
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
Ceramic Insert (biolox ® Delta), D36/48g by BEZNOSKA, s.r.o. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08592602248048 | Class III | Active |
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Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED f0b96470-4f2f-4210-b183-7686308a46b6 61 fields · synced Jun 18, 2026