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Biotek
EUDAMEDClass IIb (EU MDR)
Ref 10179Model Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw
Identity
- Trade Name
- BIOTEK EUDAMED
- Device Name
- BIOTEK, SOFTFIX, SOFTFIX-PK EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Device - Soft Tissue & Bone Fixation Screw EUDAMED10179 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210302710 EUDAMED
- Basic UDI-DI
- 89042103cmplimp006XH EUDAMED
- EMDN Code
- P09120601,P09120603 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
Yes
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
Biotek 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 | 89042103cmplimp006XH | 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 6f10ec8e-2a66-4881-8584-ba6688ae1a8c 61 fields · synced Jun 19, 2026