← Back to catalogue
Estradiol Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kitRef 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kitRef 215070006Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/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
- Estradiol Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED100tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215070006 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
- 06972719604524 EUDAMED06972719602278 EUDAMED06972719602292 EUDAMED06972719600809 EUDAMED06972719604531 EUDAMED06972719602285 EUDAMED
- Basic UDI-DI
- B-06972719604524 EUDAMEDB-06972719602278 EUDAMEDB-06972719602292 EUDAMEDB-06972719600809 EUDAMEDB-06972719604531 EUDAMEDB-06972719602285 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL 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
Estradiol Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — 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-06972719604524 | 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 (6)
- EUDAMED 0d6f3567-9a20-4646-b5a7-7918ebab1f3b 61 fields · synced Oct 6, 2026
- EUDAMED a548ae63-2695-4967-a36e-fd1bb8cfd291 61 fields · synced May 17, 2026
- EUDAMED 6407f420-1850-4fff-9e41-7993cbf34ac1 61 fields · synced May 17, 2026
- EUDAMED 762da5ac-2e90-4637-9b95-69e647ee010e 61 fields · synced May 17, 2026
- EUDAMED 75331fb1-beb2-4841-8caa-2c22003985e6 61 fields · synced May 19, 2026
- EUDAMED 296afc70-4986-4eb5-8beb-f97eb71df693 61 fields · synced May 19, 2026