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Hematology Analyzer
EUDAMEDClass B (EU MDR)
Ref 02-13-04-0011-00Model EXZ 6000Pro, EXZ 6010Pro, EXZ 6020ProRef 02-13-01-0004-00Model EXZ 6000Ref 02-13-01-0005-00Ref 3030102Model Z50
by Zybio Inc.
Identity
- Trade Name
- Hematology Analyzer EUDAMED
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- EXZ 6000Pro, EXZ 6010Pro, EXZ 6020Pro EUDAMED02-13-04-0011-00 EUDAMEDEXZ 6000 EUDAMED02-13-01-0004-00 EUDAMED02-13-01-0005-00 EUDAMEDZ50 EUDAMED3030102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967200901 EUDAMED06941967200932 EUDAMED06941967200949 EUDAMED06941967213123 EUDAMED
- Basic UDI-DI
- 6973262860003924 EUDAMED69732628600061ZS EUDAMED69732628630301*********ZR EUDAMED
- Direct Marketing DI
- 06941967213123 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands 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
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Hematology Analyzer by Zybio Inc. — Class B — 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 | 6973262860003924 | Class B | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (4)
- EUDAMED 3775280d-1c5a-4891-940b-c3f2b2e29dbf 61 fields · synced Aug 2, 2026
- EUDAMED eabec7c9-4145-4466-abde-f9939af2f7cc 61 fields · synced May 17, 2026
- EUDAMED 7913d1ad-d152-4fe2-abcc-52135ebd909a 61 fields · synced May 18, 2026
- EUDAMED 6d768d43-a2c5-42d8-b2ff-74de458bb356 61 fields · synced May 18, 2026