Identity
- Trade Name
- HAILSTORM EUDAMED
- Device Name
- HAILSTORM EUDAMED
- Model / Reference
- 00350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B350003500 EUDAMED
- Basic UDI-DI
- ++B35000350BF EUDAMED
- Direct Marketing DI
- B350003500 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Hailstorm by Gold Standard Diagnostics, LLC — 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 | ++B35000350BF | Class A | Active |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
- EUDAMED SRN
- US-MF-000027142
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 27d3ad5e-438b-458c-9e3e-ab52ae485ded 61 fields · synced Jun 19, 2026