Identity
- Device Name
- Ab Matrix Solution EUDAMED
- Model / Reference
- 052304001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967237839 EUDAMED
- Basic UDI-DI
- 6973262860011923 EUDAMED
- EMDN Code
- W0104080113 OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Ab Matrix Solution 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 | 6973262860011923 | Class A | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c85cd179-0743-473b-adbc-d0d7a8fd14c4 61 fields · synced Jun 17, 2026