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C-Reactive Protein Kit (Immunoturbidimetric Method)
EUDAMEDClass C (EU MDR)
Ref 01.09.30.00.Z.52
by Zybio Inc.
Identity
- Device Name
- C-Reactive Protein Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 01.09.30.00.Z.52 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967227137 EUDAMED
- Basic UDI-DI
- 69732628630110*********XH EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
C-Reactive Protein Kit (Immunoturbidimetric Method) by Zybio Inc. — Class C — 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 | 69732628630110*********XH | Class C | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 118c67e4-5a86-4dfe-9ff7-6fd16f36aea3 61 fields · synced Jun 18, 2026