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Strap, Leather, HHH, Smoked Elk
EUDAMEDClass I (EU MDR)
Ref Z988016Model KAFO, BK
Identity
- Trade Name
- Strap, Leather, HHH, Smoked Elk EUDAMED
- Device Name
- The Benefit KAFO EUDAMED
- Model / Reference
- KAFO, BK EUDAMEDZ988016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545156619 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, Smoked Elk 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 |
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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 ab92be79-db26-409e-8a33-184a90a98c3c 61 fields · synced Jun 19, 2026