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Myoglobin STAT (MYO STAT) eCLIA
EUDAMEDClass C (EU MDR)
Ref 691038Model 50T, 2×50T, 100T, 2×100TModel 2×100T
Identity
- Trade Name
- Myoglobin STAT (MYO STAT) eCLIA EUDAMED
- Device Name
- Myoglobin STAT (MYO STAT) eCLIA EUDAMED
- Model / Reference
- 50T, 2×50T, 100T, 2×100T EUDAMED691038 EUDAMED2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063331 EUDAMED
- Basic UDI-DI
- 69703416803205035JE EUDAMEDB-06975984063331 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
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
New Device
No
EUDAMED
Myoglobin STAT (MYO STAT) eCLIA by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69703416803205035JE | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205035JE | Class C | 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 a1e3f3ed-fad2-4851-a7f3-17d79ad73131 61 fields · synced Jun 19, 2026
- EUDAMED 45ad1c97-7886-4e8d-8543-ee22520f8daa 61 fields · synced May 18, 2026