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Check-P Control
EUDAMEDClass C (EU MDR)
Ref 01.09.31.01.Q.33Model Check-PRef 01.09.31.01.Q.34Ref 01.09.31.01.Q.32
by Zybio Inc.
Identity
- Device Name
- Check-P Control EUDAMED
- Model / Reference
- Check-P EUDAMED01.09.31.01.Q.33 EUDAMED01.09.31.01.Q.34 EUDAMED01.09.31.01.Q.32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967224563 EUDAMED06941967224570 EUDAMED06941967224556 EUDAMED
- Basic UDI-DI
- 6973262860006525 EUDAMED
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Check-P Control 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 | 6973262860006525 | 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 (3)
- EUDAMED 2ad713ce-8928-4f78-b65c-a22f02d0b03a 61 fields · synced Jul 21, 2026
- EUDAMED cdd982f1-f05b-4d63-8334-e4511091a6bf 61 fields · synced May 17, 2026
- EUDAMED 99f1785d-1a86-453f-b074-b9aa2500c84b 61 fields · synced May 19, 2026