← Back to catalogue
Torsion Cable, 3/8in, Right Ext, Left Int, 18.0in
EUDAMEDClass I (EU MDR)
Ref 400-1XRE-18.0Model 400
Identity
- Trade Name
- Torsion Cable, 3/8in, Right Ext, Left Int, 18.0in EUDAMED
- Device Name
- Torsions EUDAMED
- Model / Reference
- 400 EUDAMED400-1XRE-18.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545087197 EUDAMED
- Basic UDI-DI
- 194545400Q3 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER 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
Torsion Cable, 3/8in, Right Ext, Left Int, 18.0in 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 f60dfd84-c0ce-4a3c-a863-f8e813bbc8a7 61 fields · synced Jul 10, 2026