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Biotech Offset Quattro Stem w. HA coating
EUDAMEDClass III (EU MDR)
Ref 009-1211-1011Model BQS Hip Stem System
by Biotech GmbH
Identity
- Trade Name
- Biotech Offset Quattro Stem w. HA coating EUDAMED
- Model / Reference
- BQS Hip Stem System EUDAMED009-1211-1011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049852195898 EUDAMED
- Basic UDI-DI
- B-04049852195898 EUDAMED
- EMDN Code
- P090804010201 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT 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
Biotech Offset Quattro Stem w. HA 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-04049852195898 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED a3d03c5f-b084-490b-9c5f-976851074fcf 61 fields · synced Sep 30, 2026