Identity
- Trade Name
- Z3 EUDAMED
- Device Name
- Hematology analyzer EUDAMED
- Model / Reference
- Z3 EUDAMED3020104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262861402 EUDAMED
- Basic UDI-DI
- 6973262863020104*******AX EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Z3 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 | 6973262863020104*******AX | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 75157e6a-c8f7-4bd2-a78c-9b8ec7094031 61 fields · synced Jun 18, 2026