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Insulin Assay (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0603201
by Zybio Inc.
Identity
- Device Name
- Insulin Assay (CLIA) EUDAMED
- Model / Reference
- 0603201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967231363 EUDAMED
- Basic UDI-DI
- B-06941967231363 EUDAMED
- EMDN Code
- W0102060103 INSULIN EUDAMED
Classification
- Device Class
- Class IVD General 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
Insulin Assay (CLIA) by Zybio Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06941967231363 | Class IVD General | 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 e76a2833-8f78-447f-9859-9a1289bdb925 61 fields · synced Jun 19, 2026