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BA Modular Acetabular Press-fit shell MM w. Hydroxyapatite coating
EUDAMEDClass III (EU MDR)
Ref 031-1229-1076Model Biotech Acetabular Cup System
by Biotech GmbH
Identity
- Trade Name
- BA Modular Acetabular Press-fit shell MM w. Hydroxyapatite coating EUDAMED
- Model / Reference
- Biotech Acetabular Cup System EUDAMED031-1229-1076 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049852015394 EUDAMED
- Basic UDI-DI
- B-04049852015394 EUDAMED
- EMDN Code
- P090803010201 PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
BA Modular Acetabular Press-fit shell MM w. Hydroxyapatite coating by Biotech GmbH — 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-04049852015394 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED cb5e025b-9cd8-4690-8b95-2c218300e8ee 61 fields · synced Sep 17, 2026