← Back to catalogue
Cyfra 21-1 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit
Identity
- Device Name
- Cyfra 21-1 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMED50tests/kit EUDAMEDReagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719602919 EUDAMED06972719604425 EUDAMED06972719602902 EUDAMED
- Basic UDI-DI
- B-06972719602919 EUDAMEDB-06972719604425 EUDAMEDB-06972719602902 EUDAMED
- EMDN Code
- W0102030111 CYFRA 21-1 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Cyfra 21-1 Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
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 | B-06972719602919 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED ca979108-239f-4401-8726-f3359429aee7 61 fields · synced Oct 7, 2026
- EUDAMED 34dd6d28-2980-40a4-ab32-4ebefc7fb636 61 fields · synced May 19, 2026
- EUDAMED b646d2d2-5de0-41f1-b87f-1f67427fa4b5 61 fields · synced May 19, 2026