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Bio-Vim -lrt
EUDAMEDClass III (EU MDR)
Ref 10412Model Bioabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture Anchor
Identity
- Trade Name
- BIO-VIM -LRT EUDAMED
- Device Name
- BIOTEK, BIO-VIM, BIO-VIM LRP, BIO-VIM LRT, ARTHROVIMS BR Anchor EUDAMED
- Model / Reference
- Bioabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture Anchor EUDAMED10412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210305513 EUDAMED
- Basic UDI-DI
- 89042103cmplimp001X7 EUDAMED
- EMDN Code
- H9007 ANCHORS FOR SOFT TISSUE SUTURE (excluding P09120102 ANCHORS FOR TENDON-LIGAMENT SYNTHESIS) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
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
Bio-Vim -lrt by Chetan Meditech Pvt. Ltd. — Class III — 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 | 89042103cmplimp001X7 | Class III | 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 da02cf04-9731-4aea-8aa6-c0a97544bc45 61 fields · synced Jun 18, 2026