Identity
- Trade Name
- NL SOLUTION (Prefilled) EUDAMED
- Device Name
- NL SOLUTION (Prefilled) EUDAMED
- Model / Reference
- HK043X020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80575074301774 EUDAMED
- Basic UDI-DI
- 805750743HK04366 EUDAMED
- EMDN Code
- W0105900201 BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
NL SOLUTION (Prefilled) by Hyris Srl — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 805750743HK04366 | Class A | Active |
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Manufacturer
- Manufacturer
- Hyris Srl
- EUDAMED SRN
- IT-MF-000031635
Sources (1)
- EUDAMED a846f1bd-4321-4c04-a28a-7240dc27c691 61 fields · synced Jun 19, 2026