ONLoc
by Chetan Meditech Pvt. Ltd. 11 variants
Part of a family of 185 devices: see the family page
Ref BAK-7035Model Measurable Arthroscopy and Orthopaedic Instruments
ONLoc (BAK-7035) is a Class I device made by Chetan Meditech Pvt. Ltd., registered in EUDAMED on 25 Apr 2025 (Basic UDI-DI 89042103cmplins003YB) with CE/MDR certificate 2024-MDR/QS-040 valid until 1 Jul 2029, active as of 25 Oct 2026.
Active
CE MDR
Valid until
1 Jul 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number89042103cmplins003YB 18904210397433 | Date25 Apr 2025 | StatusActive |
Official records
- EUDAMED public site 89042103cmplins003YB
Certificates
- 2024-MDR/QS-040 Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 1 Jul 2024
- Expires
- 1 Jul 2029
Timeline
- Certificate issued EUDAMED 2024-MDR/QS-040
- Registered EUDAMED 89042103cmplins003YB
- Certificate expires EUDAMED 2024-MDR/QS-040
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- BIOTEK, Cannudrill, Flowertip, AI Reamer, Shuttleferry, Shuttleferry I, sHUTTLEFERRY II, Arthrovims OnLoc
- Model / reference
- Measurable Arthroscopy and Orthopaedic Instruments, BAK-7035
- Primary DI / UDI-DI
- 18904210397433
- Basic UDI-DI
- 89042103cmplins003YB
- EMDN code
- L0923, L1912
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- IN-MF-000013541
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Similar devices in this category
Other devices filed under ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE.
- Shoulder Instruments 04.01.10.0650 by Medacta International SA
- LnK Spinal Instrument System LC04-0108T by L&K Biomed
- INTRAUMA SURGICAL INSTRUMENT S23 by INTRAUMA SPA
- Surgical Manual Instrument 03.51.10.0144 by Medacta International SA
- LnK Spinal Instrument System LCAB-2008 by L&K Biomed
- GAP ENDO-EXO MEDULLARY SYSTEM GAP-RUL200 by Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate system POP-TRI100 by ORTHOPEDIATRICS CANADA ULC
- The GAP Nail Endo-Exo Medullary System GAP-DSA150 by ORTHOPEDIATRICS CANADA ULC
- IBS™ G01 00171 by In2Bones SAS
- ELOS INSTRUMENTS SE223 by INTRAUMA SPA