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Shoulder Bushing Screw(92095A189)
EUDAMEDClass I (EU MDR)
Ref Z970062Model TAAJ
Identity
- Trade Name
- Shoulder Bushing Screw(92095A189) EUDAMED
- Device Name
- Triple Action Ankle Joint EUDAMED
- Model / Reference
- TAAJ EUDAMEDZ970062 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545111014 EUDAMED
- Basic UDI-DI
- 194545TAAXE EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Shoulder Bushing Screw(92095A189) by Becker Orthopedic Appliance Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 194545TAAXE | Class I | Active |
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Manufacturer
- Manufacturer
- Becker Orthopedic Appliance Company
- EUDAMED SRN
- US-MF-000004002
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 9f10fb47-aa27-4842-8942-355bc2f70ae0 61 fields · synced Jun 18, 2026