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Bio-Vim
EUDAMEDClass III (EU MDR)
Ref 10410Model Bioabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture AnchorRef 10079Ref 10409Ref 10080Ref 10078Ref 10076Ref 10159
Identity
- Trade Name
- BIO-VIM EUDAMEDBIO-VIM -LRP 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 EUDAMED10410 EUDAMED10079 EUDAMED10409 EUDAMED10080 EUDAMED10078 EUDAMED10076 EUDAMED10159 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210305490 EUDAMED18904210302277 EUDAMED18904210305483 EUDAMED18904210302284 EUDAMED18904210302260 EUDAMED18904210302246 EUDAMED18904210302512 EUDAMED
- Basic UDI-DI
- 89042103cmplimp001X7 EUDAMED
- EMDN Code
- H9007,P09120102 EUDAMEDH9007 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 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 (7)
- EUDAMED bacad5a0-2ce4-47eb-ae60-38f5cc70ea20 61 fields · synced Sep 30, 2026
- EUDAMED 927c31e4-f561-45e2-81b4-070e8685ca5c 61 fields · synced May 16, 2026
- EUDAMED f20ca136-feb9-4f53-9e56-f814e76b6880 61 fields · synced May 18, 2026
- EUDAMED 402efab6-d547-4e7e-94e6-cf4a1f804649 61 fields · synced May 18, 2026
- EUDAMED 34f1b3a3-2ec4-4bff-90a0-c3df3f71e044 61 fields · synced May 18, 2026
- EUDAMED deb9af16-ff2a-4cf9-9784-4f5b3a68e8ed 61 fields · synced May 18, 2026
- EUDAMED 02338bf6-d3b3-4775-99fa-22a83f5cccc3 61 fields · synced May 19, 2026