← Back to catalogue
Bilateral Hip-KAFO Torsion Splint, 5/16in
EUDAMEDClass I (EU MDR)
Ref K-400AModel 400
Identity
- Trade Name
- Bilateral Hip-KAFO Torsion Splint, 5/16in EUDAMED
- Device Name
- Torsions EUDAMED
- Model / Reference
- 400 EUDAMEDK-400A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 90194545096710 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-KAFO Torsion Splint, 5/16in 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becker Orthopedic Appliance Company
- EUDAMED SRN
- US-MF-000004002
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED d3a5e033-9fc0-472c-8541-cfafabe57b27 61 fields · synced Jun 19, 2026