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VertoCure Cement Delivery System
EUDAMEDClass I (EU MDR)
Ref 80E1AS0005MModel Mixing and Injection System for Bone Cement
by Teknimed Sas
Identity
- Trade Name
- VertoCure Cement Delivery System EUDAMED
- Device Name
- S5M EUDAMED
- Model / Reference
- Mixing and Injection System for Bone Cement EUDAMED80E1AS0005M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760177047013 EUDAMED
- Basic UDI-DI
- 376017704B24D6 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
VertoCure Cement Delivery System by Teknimed Sas — 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 | 376017704B24D6 | Class I | Active |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-MF-000001224
Sources (1)
- EUDAMED 8edc9587-269e-455f-961c-31de0a36795d 61 fields · synced Jun 19, 2026