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Cal-P Calibrator
EUDAMEDClass C (EU MDR)
Ref 01.09.31.00.01.04Model Cal-PRef 01.09.31.00.01.03
by Zybio Inc.
Identity
- Device Name
- Cal-P Calibrator EUDAMED
- Model / Reference
- Cal-P EUDAMED01.09.31.00.01.04 EUDAMED01.09.31.00.01.03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967224549 EUDAMED06941967224532 EUDAMED
- Basic UDI-DI
- 6973262860006423 EUDAMED
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS 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
Cal-P Calibrator 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 | 6973262860006423 | 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 (2)
- EUDAMED 801ff870-4a87-49c5-a99d-82ee4c07b481 61 fields · synced Jul 14, 2026
- EUDAMED 9132f734-ea6f-4c07-9b81-238113db6eb7 61 fields · synced May 18, 2026