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ONLoc
EUDAMEDClass I (EU MDR)
Ref BAK-7035(d)Model Measurable Arthroscopy and Orthopaedic InstrumentsRef BAK-7035(b)Ref BAK-7035-3Ref BAK-7035-2Ref BAK-7035(f)
Identity
- Trade Name
- ONLoc EUDAMED
- Device Name
- BIOTEK, Cannudrill, Flowertip, AI Reamer, Shuttleferry, Shuttleferry I, sHUTTLEFERRY II, Arthrovims OnLoc EUDAMED
- Model / Reference
- Measurable Arthroscopy and Orthopaedic Instruments EUDAMEDBAK-7035(d) EUDAMEDBAK-7035(b) EUDAMEDBAK-7035-3 EUDAMEDBAK-7035-2 EUDAMEDBAK-7035(f) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210397471 EUDAMED18904210397457 EUDAMED18904210397419 EUDAMED18904210397402 EUDAMED18904210394111 EUDAMED
- Basic UDI-DI
- 89042103cmplins003YB EUDAMED
- EMDN Code
- L1912 ARTHROSCOPIC SURGERY GUIDES, REUSABLE EUDAMEDL0923,L1912 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ONLoc by Chetan Meditech Pvt. Ltd. — 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 | 89042103cmplins003YB | Class I | Active |
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Manufacturer
- Manufacturer
- Chetan Meditech Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000013541
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (5)
- EUDAMED 37a84b01-4a16-41d8-9aeb-88b4d8e8d715 61 fields · synced Sep 17, 2026
- EUDAMED 6b6bd757-f663-4352-81fb-32846d4521a4 61 fields · synced May 18, 2026
- EUDAMED ce66a72e-7408-4fbf-9d1d-6ee4ddcdf589 61 fields · synced Jul 9, 2026
- EUDAMED 83bcebf2-6438-4a57-9034-25bd11a4c864 61 fields · synced Jul 14, 2026
- EUDAMED fbd235f4-ecd6-4b39-a89c-d05982708f49 61 fields · synced Sep 17, 2026