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Torsion Pelvic Band w/5/16in HJT, 15.5-16.5in Circ
EUDAMEDClass I (EU MDR)
Ref 400-9A-16Model 400
Identity
- Trade Name
- Torsion Pelvic Band w/5/16in HJT, 15.5-16.5in Circ EUDAMED
- Device Name
- Torsions EUDAMED
- Model / Reference
- 400 EUDAMED400-9A-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545088316 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 Pelvic Band w/5/16in HJT, 15.5-16.5in 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 |
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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 a947538d-3801-4269-84d2-a9b3f597e5cc 61 fields · synced Jun 19, 2026