Identity
- Trade Name
- GIS Gas Injection Set EUDAMED
- Device Name
- GIS Gas Injection Set EUDAMED
- Model / Reference
- GIS 001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18021118000415 EUDAMED
- Basic UDI-DI
- B-18021118000415 EUDAMED
- EMDN Code
- A010599 OPHTHALMOLOGY INJECTION NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
GIS Gas Injection Set by Al.chi.mi.a. S.r.l. — 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-18021118000415 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Al.chi.mi.a. S.r.l.
- EUDAMED SRN
- IT-MF-000028901
Sources (1)
- EUDAMED 7eb91457-98b1-4ad5-b353-9a11af119671 61 fields · synced Jul 30, 2026