BUTTONFIX-F Mini
by Chetan Meditech Pvt. Ltd. India EUDAMED
Ref 10450Model Nonabsorbable Soft Tissue & Bone Fixation Devices - Fixation Buttons with/without Suture Loops
EMDN H900301,P09120102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number89042103cmplimp004XD | Date8 Apr 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2024-MDR/QS-033 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 1 Jul 2024
- Expires
- 1 Jul 2029
- 2024-MDR/TD-033 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 7 Jan 2024
- Expires
- 7 Jan 2029
Specification
- Device Name
- BIOTEK, ONButton, ONButton-Ex, AK-FIX, WT-FIX, MR-FIX, PIVOT-FIX, AC-FIX, SMARTFIX, SUTUREFIX, BT-FIX, ONButton CL, BUTTONFIX, BUTTONFIX-F, BUTTONFIX-W,
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Devices - Fixation Buttons with/without Suture Loops, 10450
- Primary DI / UDI-DI
- 18904210305834
- Basic UDI-DI
- 89042103cmplimp004XD
- EMDN Code
- H900301,P09120102
- Device Class
- Class IIb
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- IN-MF-000013541
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Chetan Meditech Pvt. Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 18904210305834|89042103CMPLIMP004XD