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Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref 02-13-01-0003-00Model EXZ6000Model EXZ 6000
by Zybio Inc.
Identity
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- EXZ6000 EUDAMED02-13-01-0003-00 EUDAMEDEXZ 6000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967200925 EUDAMED
- Basic UDI-DI
- B-06941967200925 EUDAMED69732628600061ZS EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany 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
Hematology Analyzer by Zybio 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-06941967200925 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06941967200925 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 789c716d-2b67-4ddc-93ff-9e1577134beb 61 fields · synced Sep 17, 2026
- EUDAMED 0c98d25a-fd18-4b14-8a79-8a669f92c091 61 fields · synced May 19, 2026