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PE Dual mobility acetabular insert for APOGEE cup, Ø22, size 44
EUDAMEDClass III (EU MDR)
Ref IDM22-44+
Identity
- Device Name
- PE Dual mobility acetabular insert for APOGEE cup, Ø22, size 44 EUDAMED
- Model / Reference
- IDM22-44+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700401675575 EUDAMED
- Basic UDI-DI
- B-03700401675575 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, Ø22, size 44 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-03700401675575 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotechni S.A.S
- EUDAMED SRN
- FR-MF-000013608
Sources (1)
- EUDAMED 7cc9b045-484d-4cb8-a23b-f610227276ec 61 fields · synced Jul 28, 2026