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Zybio
EUDAMEDClass A (EU MDR)
Ref Sample Probe Cleaning SolutionModel /
by Zybio Inc.
Identity
- Trade Name
- Zybio EUDAMED
- Device Name
- Sample Probe Cleaning Solution EUDAMED
- Model / Reference
- / EUDAMEDSample Probe Cleaning Solution EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967236757 EUDAMED
- Basic UDI-DI
- 69732628600120ZH EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Zybio by Zybio Inc. — Class A — 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 | 69732628600120ZH | Class A | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 27fb8d9d-61bd-4fab-bf6c-e789fa35a226 61 fields · synced Jun 20, 2026