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AJT, DBL ACT, SLO, SS, C8 Alum Upr, HP
EUDAMEDClass I (EU MDR)
Ref SLO-2835-C8-1Model Double Action Ankle Components
Identity
- Trade Name
- AJT, DBL ACT, SLO, SS, C8 Alum Upr, HP EUDAMED
- Device Name
- Double Action Ankle Components EUDAMED
- Model / Reference
- Double Action Ankle Components EUDAMEDSLO-2835-C8-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545038861 EUDAMED
- Basic UDI-DI
- 194545DBLACTANKLE86 EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
AJT, DBL ACT, SLO, SS, C8 Alum Upr, HP 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 | 194545DBLACTANKLE86 | Class I | Active |
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Manufacturer
- Manufacturer
- Becker Orthopedic Appliance Company
- EUDAMED SRN
- US-MF-000004002
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 9c719515-f986-4f98-95eb-33768a3f7515 61 fields · synced Oct 6, 2026