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Auto Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref KT-6600Ref KT-8000Ref KT-6610Ref KT-6500Ref KT-6300
Identity
- Trade Name
- Auto Hematology Analyzer EUDAMED
- Device Name
- Auto Hematology Analyzer EUDAMED
- Model / Reference
- KT-6600 EUDAMEDKT-8000 EUDAMEDKT-6610 EUDAMEDKT-6500 EUDAMEDKT-6300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334802433 EUDAMED06950334809081 EUDAMED06950334802440 EUDAMED06950334802419 EUDAMED06950334802334 EUDAMED
- Basic UDI-DI
- B-06950334802433 EUDAMEDB-06950334809081 EUDAMEDB-06950334802440 EUDAMEDB-06950334802419 EUDAMEDB-06950334802334 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMEDW0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMEDGermany EUDAMEDRomania 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
Auto Hematology Analyzer by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06950334802433 | Class IVD General | 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 (5)
- EUDAMED 83a2bb79-7d1e-40f3-a348-1994831a98f6 61 fields · synced Jul 31, 2026
- EUDAMED fbbca108-4724-4b82-9eb1-58c74d13883d 61 fields · synced May 17, 2026
- EUDAMED 7a86c1e1-abc0-4bdf-beef-bf0f54a0a565 61 fields · synced May 18, 2026
- EUDAMED 2fea7b31-62b8-4b29-84da-ed715524720f 61 fields · synced May 18, 2026
- EUDAMED d73607e2-37d4-4e47-8138-54d0c0125036 61 fields · synced Jul 9, 2026