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KT03 Lyse Solution
EUDAMEDClass A (EU MDR)
Ref 22019001Model Please see UDI-DIs for details.
Identity
- Trade Name
- KT03 Lyse Solution EUDAMED
- Device Name
- KT03/KT03A Lyse Solution EUDAMED
- Model / Reference
- Please see UDI-DIs for details. EUDAMED22019001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334802501 EUDAMED
- Basic UDI-DI
- 69503348KTA002KR EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
KT03 Lyse Solution by Genrui Biotech Inc. — 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 | 69503348KTA002KR | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9de78d22-a9ce-4f78-af74-ff6335789fdb 61 fields · synced Jun 18, 2026