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Bilateral Hip-Ankle Torsion Splint, 3/8in
EUDAMEDClass I (EU MDR)
Ref L-400XModel 400
Identity
- Trade Name
- Bilateral Hip-Ankle Torsion Splint, 3/8in EUDAMED
- Device Name
- Torsions EUDAMED
- Model / Reference
- 400 EUDAMEDL-400X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 90194545097885 EUDAMED
- Basic UDI-DI
- 194545400Q3 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER 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
Bilateral Hip-Ankle Torsion Splint, 3/8in 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 | 194545400Q3 | 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 636fa9be-58a2-4255-9e8a-907c32168fde 61 fields · synced Jun 18, 2026