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C-Reactive Protein Kit (Immunoturbidimetric Method)
EUDAMEDClass C (EU MDR)
Ref 01.09.30.00.Z.43Ref 01.09.30.00.Z.50Ref 06941967227083Ref 01.09.30.00.Z.45Ref 01.09.30.00.Z.53Ref 01.09.30.00.Z.51
by Zybio Inc.
Identity
- Device Name
- C-Reactive Protein Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 01.09.30.00.Z.43 EUDAMED01.09.30.00.Z.50 EUDAMED06941967227083 EUDAMED01.09.30.00.Z.45 EUDAMED01.09.30.00.Z.53 EUDAMED01.09.30.00.Z.51 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967227045 EUDAMED06941967227113 EUDAMED06941967227083 EUDAMED06941967227069 EUDAMED06941967227144 EUDAMED06941967227120 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 (6)
- EUDAMED 3ebca83e-95b4-4b9f-b9b1-4a63e88d64c2 61 fields · synced Aug 3, 2026
- EUDAMED 0fd866e5-2382-473a-a9ba-24746fc1b741 61 fields · synced May 11, 2026
- EUDAMED 80d6123b-1a71-46bc-a2b6-a5b53785c83a 61 fields · synced May 16, 2026
- EUDAMED e99ace9b-5567-46ad-a49e-cfc96fb6fb43 61 fields · synced May 16, 2026
- EUDAMED f2a6b4fb-9461-41d7-9e0c-dd9e447e8bb1 61 fields · synced May 16, 2026
- EUDAMED d358082d-342c-44de-94dd-fe56011a9772 61 fields · synced May 18, 2026