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KJT, Auto Trigger LCK, ALUM, 1/4 x 3/4, PR/RMC
EUDAMEDClass I (EU MDR)
Ref 1011-A4-WZModel 1011
Identity
- Trade Name
- KJT, Auto Trigger LCK, ALUM, 1/4 x 3/4, PR/RMC EUDAMED
- Device Name
- Automatic Trigger Lock Knee Joint EUDAMED
- Model / Reference
- 1011 EUDAMED1011-A4-WZ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545135089 EUDAMED
- Basic UDI-DI
- 19454510116R EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES 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
KJT, Auto Trigger LCK, ALUM, 1/4 x 3/4, PR/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 | 19454510116R | 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 ca613844-066b-49e3-ac9d-e33e5f650884 61 fields · synced Jun 19, 2026