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Myoglobin (Myo) Assay Kits (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 745008Model 25 Tests/KitRef 0320300803Model 100 Tests/Kit
Identity
- Trade Name
- Myoglobin (Myo) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Myoglobin (Myo) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED745008 EUDAMED100 Tests/Kit EUDAMED0320300803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984067353 EUDAMED06975984067674 EUDAMED
- Basic UDI-DI
- B-06975984067353 EUDAMEDB-06975984067674 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Myoglobin (Myo) Assay Kits (Lateral Flow Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06975984067353 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b4678101-ab41-4ead-88bd-ac6edc0d38f6 61 fields · synced Jul 26, 2026
- EUDAMED 27e87310-25b7-4d6d-bd14-424c43203839 61 fields · synced May 19, 2026