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Ak-Fix
EUDAMEDClass IIb (EU MDR)
Ref 10104Model Nonabsorbable Soft Tissue & Bone Fixation Devices - Fixation Buttons with/without Suture Loops
Identity
- Trade Name
- AK-FIX 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 EUDAMED10104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210302437 EUDAMED
- Basic UDI-DI
- 89042103cmplimp004XD EUDAMED
- EMDN Code
- H900301,P09120102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Ak-Fix 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 c6360b7e-8578-4887-ae86-0354aab3859e 61 fields · synced Jul 20, 2026