Identity
- Trade Name
- SF/II - Standard insert/N, D66/28 EUDAMED
- Device Name
- SF/II - Standard insert/N, D66/28 EUDAMED
- Model / Reference
- 332522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602121778 EUDAMED
- Basic UDI-DI
- B-08592602121778 EUDAMED
- EMDN Code
- P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES 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
Category: Non-constrained polyethylene acetabular liner
SF/II - Standard insert/N, D66/28 by BEZNOSKA, s.r.o. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
- C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
- PRIME — MicroPort Orthopedics Inc. · Class II
- G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
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-08592602121778 | 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 e5ccc08f-3e76-42b0-af32-fc4617e535c8 61 fields · synced Jun 19, 2026