← Back to catalogue
Myoglobin (Electrochemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref 691034Model 2×50T
Identity
- Trade Name
- Myoglobin (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Myoglobin (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 691034 EUDAMED2×50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062105 EUDAMED
- Basic UDI-DI
- 69703416803205007J9 EUDAMEDB-06975984062105 EUDAMED
- EMDN Code
- W01021304 MYOGLOBIN EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General 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 C — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69703416803205007J9 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205007J9 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
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 ce02fd54-b0f0-4b9b-9986-519a396e6d71 61 fields · synced Jun 19, 2026
- EUDAMED 9fa4f2f4-c414-4688-bd08-ff440b991371 61 fields · synced May 19, 2026