← Back to catalogue
Anatomical Extended Offset Femoral Stem
EUDAMEDClass III (EU MDR)
Ref 020-2194-1014Model SKM Hip Stem System
by Biotech GmbH
Identity
- Trade Name
- Anatomical Extended Offset Femoral Stem EUDAMED
- Model / Reference
- SKM Hip Stem System EUDAMED020-2194-1014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049852202961 EUDAMED
- Basic UDI-DI
- B-04049852202961 EUDAMED
- EMDN Code
- P090804010102 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL 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
Anatomical Extended Offset Femoral Stem 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-04049852202961 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED 837fdd63-2848-48ba-935d-d18ad6c256ed 61 fields · synced Aug 1, 2026