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Strp Only, Adult, SA Std Fl 8in Stf Ank
EUDAMEDClass I (EU MDR)
Ref 3000-A8Model Standard Action Ankle Components
Identity
- Trade Name
- Strp Only, Adult, SA Std Fl 8in Stf Ank EUDAMED
- Device Name
- Standard Action Ankle Components EUDAMED
- Model / Reference
- Standard Action Ankle Components EUDAMED3000-A8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545056261 EUDAMED
- Basic UDI-DI
- 194545STDACTANKLEZ9 EUDAMED
- EMDN Code
- Y06120601 PASSIVE 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
Category: Ankle/foot orthosis
Strp Only, Adult, SA Std Fl 8in Stf Ank by Becker Orthopedic Appliance Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 194545STDACTANKLEZ9 | 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 7b077601-b551-4e8c-bd24-8ce6f210c5c1 61 fields · synced Oct 6, 2026