Identity
- Trade Name
- Crystal EUDAMED
- Device Name
- Crystal® Dengue IgG/IgM EUDAMED
- Model / Reference
- 58IC104-25, 58IC104-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904226008869 EUDAMED
- Basic UDI-DI
- 8904226058IC104WS EUDAMED
- EMDN Code
- W0105099007 DENGUE - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Austria 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
Crystal by ARKRAY Healthcare Pvt. Ltd. — Class B — 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 | 8904226058IC104WS | Class B | Active |
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Manufacturer
- Manufacturer
- ARKRAY Healthcare Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000019015
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (2)
- EUDAMED bc83b345-0c02-4f89-9fc6-1f5bdd9cf9ae-1 61 fields · synced Jul 11, 2026
- EUDAMED bc83b345-0c02-4f89-9fc6-1f5bdd9cf9ae-2 61 fields · synced Jul 11, 2026