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CYFRA 21-1 Assay (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0603901
by Zybio Inc.
Identity
- Device Name
- CYFRA 21-1 Assay (CLIA) EUDAMED
- Model / Reference
- 0603901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967231509 EUDAMED
- Basic UDI-DI
- B-06941967231509 EUDAMED
- EMDN Code
- W0102030111 CYFRA 21-1 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
CYFRA 21-1 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-06941967231509 | 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 e89cb803-94d5-47ea-83d4-a3d00c75db4c 61 fields · synced Jul 9, 2026