← Back to catalogue
Auto Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref KT-42Model KT-62, KT-60, KT-40, KT-42
Identity
- Trade Name
- Auto Hematology Analyzer EUDAMED
- Device Name
- Auto Hematology Analyzer EUDAMED
- Model / Reference
- KT-42 EUDAMEDKT-62, KT-60, KT-40, KT-42 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334802396 EUDAMED
- Basic UDI-DI
- B-06950334802396 EUDAMED69503348KT06RT EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye 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
No
EUDAMED
Auto Hematology Analyzer by Genrui Biotech Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06950334802396 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06950334802396 | Class IVD General | 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 (2)
- EUDAMED ab8f5000-c07e-4f11-bad4-a540d88fc068 61 fields · synced Jun 19, 2026
- EUDAMED d5ec64b9-b5d3-48bb-a379-81788e2dbdb5 61 fields · synced May 18, 2026