Identity
- Trade Name
- AUTOSPAN EUDAMED
- Device Name
- AUTOSPAN® Liquid Gold Cholesterol EUDAMED
- Model / Reference
- 71LS200-40, 71LS200-60, 71LS200-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904226002942 EUDAMED
- Basic UDI-DI
- 8904226071LS200ZF EUDAMED
- EMDN Code
- W01010205 CHOLESTEROL EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France 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
Category: Total cholesterol lipid IVD, reagent
Autospan by ARKRAY Healthcare Pvt. Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8904226071LS200ZF | 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 6fb26505-bac5-4516-a74b-278acf5320a8-1 61 fields · synced Jun 19, 2026
- EUDAMED 6fb26505-bac5-4516-a74b-278acf5320a8-2 61 fields · synced Jun 19, 2026