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Chemistry analyzer
EUDAMEDClass A (EU MDR)
Ref 02-10-00-0005-00Model EXC400, EXC420Ref 0112805Model EXC460, EXC470Ref 0112804
by Zybio Inc.
Identity
- Device Name
- Chemistry analyzer EUDAMED
- Model / Reference
- EXC400, EXC420 EUDAMED02-10-00-0005-00 EUDAMEDEXC460, EXC470 EUDAMED0112805 EUDAMED0112804 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967205678 EUDAMED06941967242291 EUDAMED06941967242284 EUDAMED
- Basic UDI-DI
- 69732628600037ZV EUDAMED6973262860014626 EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMEDW0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMEDW0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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
Chemistry analyzer 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 | 69732628600037ZV | 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 (4)
- EUDAMED 72f10ece-8861-491f-b4e5-6b81ae919fa8 61 fields · synced Jul 26, 2026
- EUDAMED aca1bec1-c948-4f0c-92ee-4132d2758664 61 fields · synced Jun 18, 2026
- EUDAMED 24ad432f-e61c-45c1-8ebf-44cfe8fbf17a 61 fields · synced Jul 17, 2026
- EUDAMED 5ebaea24-2d92-4b73-b36a-57b71d1476d4 61 fields · synced Jul 26, 2026