Identity
- Trade Name
- Jeringa Subiton GUN EUDAMED
- Device Name
- Sistema dispensador de cemento ortopédico EUDAMED
- Model / Reference
- Jeringa GUN EUDAMED880451 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798034464518 EUDAMED
- Basic UDI-DI
- B-07798034464518 EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Jeringa Subiton GUN by Laboratorios SL S.A. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07798034464518 | Class IIa | 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 b3e15ac2-cf01-40bc-b803-a38e701a033e 61 fields · synced Jun 19, 2026