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Distal Assy, OFST RNGLK KJT, 3/16 x 3/4, SQ AL RMC
EUDAMEDClass I (EU MDR)
Ref 1012A6TL10Model 1012
Identity
- Trade Name
- Distal Assy, OFST RNGLK KJT, 3/16 x 3/4, SQ AL RMC EUDAMED
- Device Name
- Posterior Offset Ring Lock Knee Joint EUDAMED
- Model / Reference
- 1012 EUDAMED1012A6TL10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545071257 EUDAMED
- Basic UDI-DI
- 19454510126T 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
Distal Assy, OFST RNGLK KJT, 3/16 x 3/4, SQ AL RMC 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 | 19454510126T | 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 e98e0c09-ecf8-4e99-b259-4cbb448cc372 61 fields · synced Jun 18, 2026