Identity
- Trade Name
- CERAMIC INSERT (BIOLOX ® DELTA), D32/52G EUDAMED
- Device Name
- CERAMIC INSERT (BIOLOX ® DELTA), D32/52G EUDAMED
- Model / Reference
- 380018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602248109 EUDAMED
- Basic UDI-DI
- B-08592602248109 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), D32/52g 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-08592602248109 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED d8bb81b3-2405-4493-98c7-4a23fdbd04d1 61 fields · synced Jul 9, 2026