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Biotek
EUDAMEDClass I (EU MDR)
Ref BAK-7145Model Non Invasive Arthroscopy and Orthopaedic Instruments
Identity
- Trade Name
- BIOTEK EUDAMED
- Device Name
- BIOTEK EUDAMED
- Model / Reference
- Non Invasive Arthroscopy and Orthopaedic Instruments EUDAMEDBAK-7145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210398409 EUDAMED
- Basic UDI-DI
- 89042103cmplins006YH EUDAMED
- EMDN Code
- L1908 ARTHROSCOPIC SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
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
Biotek by Chetan Meditech Pvt. Ltd. — Class I — 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 | 89042103cmplins006YH | Class I | 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 d16f4871-1b78-4f68-aef0-8d47dada9ce7 61 fields · synced Jun 18, 2026