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Myoglobin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 215300017Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kitRef 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kitRef 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit
Identity
- Device Name
- Myoglobin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215300017 EUDAMEDReagents (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 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719600922 EUDAMED06972719601752 EUDAMED06972719604760 EUDAMED06972719604777 EUDAMED06972719601745 EUDAMED
- Basic UDI-DI
- B-06972719600922 EUDAMEDB-06972719601752 EUDAMEDB-06972719604760 EUDAMEDB-06972719604777 EUDAMEDB-06972719601745 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN 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
Myoglobin 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-06972719600922 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED e7b718da-c76a-40ef-97fb-7bb609b1898f 61 fields · synced Oct 7, 2026
- EUDAMED 1704dddb-0278-47fc-8886-1c06973a726e 61 fields · synced May 17, 2026
- EUDAMED fa8b8654-3dc8-412b-82d5-e40b972dca64 61 fields · synced May 19, 2026
- EUDAMED c231772b-eb5a-4219-9184-610f9121e9d7 61 fields · synced May 19, 2026
- EUDAMED 1df63d3b-f39d-46a7-9a0a-a1caadf87396 61 fields · synced May 19, 2026