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Biotek
EUDAMEDClass I (EU MDR)
Ref BAK-7199Model Reusable Arthroscopy and Orthopaedic Instruments
Identity
- Trade Name
- BIOTEK EUDAMED
- Device Name
- BIOTEK, Cannudrill, Flowertip, AL Reamer, BOTS, BOATS, SURESHOT, LOCUS, Shuttleferry, Shuttleferry I, Shuttleferry II, Arthrovims, OnLoc EUDAMED
- Model / Reference
- Reusable Arthroscopy and Orthopaedic Instruments EUDAMEDBAK-7199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210397327 EUDAMED
- Basic UDI-DI
- 89042103cmplins002Y9 EUDAMED
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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 | 89042103cmplins002Y9 | 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 8eb28465-687e-42da-8ed0-9ea3d8434f6b 61 fields · synced Jun 19, 2026