Identity
- Trade Name
- HEPASYS EUDAMED
- Device Name
- HEPASYS EUDAMED
- Model / Reference
- HE15-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858890492903 EUDAMED
- Basic UDI-DI
- B-03858890492903 EUDAMED
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS 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
Hepasys by ZAMAR d.o.o. — 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-03858890492903 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ZAMAR d.o.o.
- EUDAMED SRN
- HR-MF-000023545
Sources (1)
- EUDAMED 9a5c1fa4-2209-4e59-a36b-8f56937fe178 61 fields · synced Sep 18, 2026