Identity
- Trade Name
- Strap, Leather, HHH, Taupe EUDAMED
- Device Name
- The Benefit KAFO EUDAMED
- Model / Reference
- KAFO, BK EUDAMEDZ988020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545156640 EUDAMED
- Basic UDI-DI
- 194545KAFOJE EUDAMED
- EMDN Code
- Y06121201 PASSIVE KNEE-ANKLE-FOOT ORTHOSES 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
Strap, Leather, HHH, Taupe 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 | 194545KAFOJE | 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 b1decb3f-c5dc-42f5-b0d8-f36ee8dad97e 61 fields · synced Jul 24, 2026