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Myoglobin (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 691015Model 100T
Identity
- Trade Name
- Myoglobin (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Myoglobin (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100T EUDAMED691015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341680541 EUDAMED
- Basic UDI-DI
- B-06970341680541 EUDAMED69703416803205007J9 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
Myoglobin (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06970341680541 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341680541 | 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 1597d8a0-7ad9-4ff7-adb1-a9eeb74b9c4e 61 fields · synced Jul 17, 2026
- EUDAMED ee12b975-5910-4b47-8c85-fb577ced37e4 61 fields · synced May 19, 2026