← Back to catalogue
Torsion Plv Bd w/3/8in HJT, 33.5in - 34.5in Circ
EUDAMEDClass I (EU MDR)
Ref U400-9X-34-LModel 400
Identity
- Trade Name
- Torsion Plv Bd w/3/8in HJT, 33.5in - 34.5in Circ EUDAMED
- Device Name
- Torsions EUDAMED
- Model / Reference
- 400 EUDAMEDU400-9X-34-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545152338 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 Plv Bd w/3/8in HJT, 33.5in - 34.5in Circ 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
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 56958d02-6e02-47cd-8331-b0f3458599e5 61 fields · synced Jun 18, 2026