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PE Dual mobility acetabular insert for APOGEE cup, Ø28, size 60
EUDAMEDClass III (EU MDR)
Ref IDM28-60+
Identity
- Device Name
- PE Dual mobility acetabular insert for APOGEE cup, Ø28, size 60 EUDAMED
- Model / Reference
- IDM28-60+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700401675735 EUDAMED
- Basic UDI-DI
- B-03700401675735 EUDAMED
- EMDN Code
- P0908030502 DOUBLE-MOBILITY ACETABULAR COMPONENTS INSERTS 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
PE Dual mobility acetabular insert for APOGEE cup, Ø28, size 60 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-03700401675735 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotechni S.A.S
- EUDAMED SRN
- FR-MF-000013608
Sources (1)
- EUDAMED 52cb4854-a151-470a-96b3-218b26c3001b 61 fields · synced Jul 20, 2026