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Auto Hematology Analyzer
EUDAMEDClass B (EU MDR)
Ref 21000028Model KT-62, KT-60, KT-40, KT-42Ref KT 62
Identity
- Trade Name
- Auto Hematology Analyzer EUDAMED
- Device Name
- Auto Hematology Analyzer EUDAMED
- Model / Reference
- KT-62, KT-60, KT-40, KT-42 EUDAMED21000028 EUDAMEDKT 62 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334802372 EUDAMED
- Basic UDI-DI
- 69503348KT06RT EUDAMEDB-06950334802372 EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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 B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69503348KT06RT | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69503348KT06RT | Class B | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 9c5796c1-dea6-4012-8528-c5b74d30857d 61 fields · synced Jul 13, 2026
- EUDAMED 900bd9ff-fd8b-46d3-ac04-6139d7f611e9 61 fields · synced May 18, 2026