Identity
- Trade Name
- Pistola SUBIMIX EUDAMED
- Device Name
- Pistola SUBIMIX EUDAMED
- Model / Reference
- Pistola SUBIMIX EUDAMED880522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798034467373 EUDAMED
- Basic UDI-DI
- 779803446GUN-V4SD EUDAMED
- Direct Marketing DI
- 07798034467373 EUDAMED
- EMDN Code
- L091105 CEMENTATION INSTRUMENTS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Bone-screw internal spinal fixation system, sterile
Pistola SUBIMIX by Laboratorios SL S.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Bone-screw internal spinal fixation system, sterile.
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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 | 779803446GUN-V4SD | Class I | Active |
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Manufacturer
- Manufacturer
- Laboratorios SL S.A.
- EUDAMED SRN
- AR-MF-000023153
- Authorised Representative
- Synergie Ingénierie Médicale FR-AR-000001802
Sources (1)
- EUDAMED 117aca78-5abc-4499-bd0a-84502b63ddfc 61 fields · synced Jul 16, 2026