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Strp Only, DF Plus Std Flange, 6in Tongue 14.5in
EUDAMEDClass I (EU MDR)
Ref X3200-X14.5Model Dorsi Assist Ankle Components
Identity
- Trade Name
- Strp Only, DF Plus Std Flange, 6in Tongue 14.5in EUDAMED
- Device Name
- Dorsi Assist Ankle Components EUDAMED
- Model / Reference
- Dorsi Assist Ankle Components EUDAMEDX3200-X14.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545161422 EUDAMED
- Basic UDI-DI
- 194545DORSIANKLEBN 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
Strp Only, DF Plus Std Flange, 6in Tongue 14.5in 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 | 194545DORSIANKLEBN | 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 1cbcdc53-6080-4aee-a28a-4d5f9a7afefc 61 fields · synced Jun 19, 2026