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IGLOO 18° threaded acetabular cup, Ti+HA coated - S54
EUDAMEDClass III (EU MDR)
Ref CIG-54TH
Identity
- Device Name
- IGLOO 18° threaded acetabular cup, Ti+HA coated - S54 EUDAMED
- Model / Reference
- CIG-54TH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700401612563 EUDAMED
- Basic UDI-DI
- B-03700401612563 EUDAMED
- EMDN Code
- P090803010201 PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
IGLOO 18° threaded acetabular cup, Ti+HA coated - S54 by Biotechni S.A.S — 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-03700401612563 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotechni S.A.S
- EUDAMED SRN
- FR-MF-000013608
Sources (1)
- EUDAMED da708d52-1bb4-4521-b139-06a5963b1e63 61 fields · synced Jul 15, 2026