Identity
- Trade Name
- General Test Pack 500 Test EUDAMED
- Device Name
- General Test Pack 500 Test EUDAMED
- Model / Reference
- CYK000030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050999100382 EUDAMED
- Basic UDI-DI
- 805099910GYK001ED EUDAMED
- EMDN Code
- W01030705,W01030799,W0503020202,W0503900201,W0599 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
General Test Pack 500 Test by Hospitex International S.r.l. — 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 | 805099910GYK001ED | Class A | Active |
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Manufacturer
- Manufacturer
- Hospitex International S.r.l.
- EUDAMED SRN
- IT-MF-000041985
Sources (1)
- EUDAMED 9c979dc1-6798-490d-90a0-c5a2f250e5a5 61 fields · synced Jun 20, 2026