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Biocinch
EUDAMEDClass IIb (EU MDR)
Ref BAK-7196Model Nonabsorbable Soft Tissue & Bone Fixation Device - Meniscal Repair Devices
Identity
- Trade Name
- BIOCINCH EUDAMED
- Device Name
- BIOTEK, BIOCINCH, BIOCINCH-AI2 EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Device - Meniscal Repair Devices EUDAMEDBAK-7196 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210301140 EUDAMED
- Basic UDI-DI
- 89042103cmplimp005XF EUDAMED
- EMDN Code
- H0102010299,H9007,P09120102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Biocinch 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 | 89042103cmplimp005XF | 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 3cd7cf48-da6e-4d4d-ae41-09c5b88227c6 61 fields · synced Jun 18, 2026