Identity
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- Z50 EUDAMED3030104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967213130 EUDAMED
- Basic UDI-DI
- 69732628630301*********ZR EUDAMED
- Direct Marketing DI
- 06941967213130 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B 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
No
EUDAMED
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 | 69732628630301*********ZR | 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 (1)
- EUDAMED bbc9fdef-6bf0-4963-b174-83a2edd46b0a 61 fields · synced Jun 19, 2026