Identity
- Trade Name
- MEGRA Lyse -FDT EUDAMED
- Device Name
- CelQuant 3i Lyse EUDAMED
- Model / Reference
- CLYCCR-03 EUDAMEDFDTCCR-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905459000859 EUDAMED
- Basic UDI-DI
- 8905459BCLR8K EUDAMED
- Direct Marketing DI
- 08905459000859 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Bulgaria 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
No
EUDAMED
New Device
No
EUDAMED
MEGRA Lyse -FDT by Meril Diagnostics Pvt. Ltd. — 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 | 8905459BCLR8K | Class A | Active |
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Manufacturer
- Manufacturer
- Meril Diagnostics Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000028158
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c7162bf4-149a-4abe-b591-38bb61c2e6c1 61 fields · synced Jun 19, 2026