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KJT, Mod Ring Lock, ALUM, 1/8 x 1/2, PR
EUDAMEDClass I (EU MDR)
Ref 1002-I8-WXModel 1002
Identity
- Trade Name
- KJT, Mod Ring Lock, ALUM, 1/8 x 1/2, PR EUDAMED
- Device Name
- Modified Ring Lock Knee Joint EUDAMED
- Model / Reference
- 1002 EUDAMED1002-I8-WX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545001209 EUDAMED
- Basic UDI-DI
- 19454510026Q 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, Mod Ring Lock, ALUM, 1/8 x 1/2, PR 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 | 19454510026Q | Class I | Active |
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Manufacturer
- Manufacturer
- Becker Orthopedic Appliance Company
- EUDAMED SRN
- US-MF-000004002
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 3fd579ad-bc51-4cee-9c40-ed779f2cd250 61 fields · synced Jun 18, 2026