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Smartfix
EUDAMEDClass IIb (EU MDR)
Ref 10542Model Nonabsorbable Soft Tissue & Bone Fixation Devices - Fixation Buttons with/without Suture Loops
Identity
- Trade Name
- SMARTFIX EUDAMED
- 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, EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Devices - Fixation Buttons with/without Suture Loops EUDAMED10542 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210306503 EUDAMED
- Basic UDI-DI
- 89042103cmplimp004XD EUDAMED
- EMDN Code
- H900301,P09120102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
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
Smartfix by Chetan Meditech Pvt. Ltd. — Class IIb — 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 | 89042103cmplimp004XD | Class IIb | 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 (1)
- EUDAMED a28fb478-d3fe-49f6-9aad-99821cbe8abf 61 fields · synced Jul 30, 2026