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Strp Only, Wide, SA Wide Fl 8in E Stop
EUDAMEDClass I (EU MDR)
Ref W3000-A8EModel Standard Action Ankle Components
Identity
- Trade Name
- Strp Only, Wide, SA Wide Fl 8in E Stop EUDAMED
- Device Name
- Standard Action Ankle Components EUDAMED
- Model / Reference
- Standard Action Ankle Components EUDAMEDW3000-A8E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545042202 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
Strp Only, Wide, SA Wide Fl 8in E Stop 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 | 194545STDACTANKLEZ9 | 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 84e277fc-e988-4d9d-9244-24dc379d8a83 61 fields · synced Jun 18, 2026