← Back to catalogue
Glava parcijalne biartikularne proteze kuka-femoralna glava
EUDAMEDClass IIb (EU MDR)
Ref TCP 28GLModel Head of partial bairticular hip prosthesis-femoral head
Identity
- Trade Name
- Glava parcijalne biartikularne proteze kuka-femoralna glava EUDAMED
- Device Name
- Head of partial bairticular hip prosthesis-femoral head EUDAMED
- Model / Reference
- Head of partial bairticular hip prosthesis-femoral head EUDAMEDTCP 28GL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08605029609399 EUDAMED
- Basic UDI-DI
- B-08605029609399 EUDAMED
- EMDN Code
- P090804050102 METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Metallic femoral head prosthesis
Glava parcijalne biartikularne proteze kuka-femoralna glava by Narcissus doo — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
- Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · 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-08605029609399 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Narcissus doo
- EUDAMED SRN
- RS-MF-000022423
- Authorised Representative
- Narcmed Kft. HU-AR-000020491
Sources (1)
- EUDAMED 50494cb3-952a-4ae1-ba02-aa7c85b53aec 61 fields · synced Jun 18, 2026