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Serum Amyloid A (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320502003Model 100 TRef 0320502004Model 2×100 T
Identity
- Trade Name
- Serum Amyloid A (eCLIA) EUDAMED
- Device Name
- Serum Amyloid A (eCLIA) EUDAMED
- Model / Reference
- 100 T EUDAMED0320502003 EUDAMED2×100 T EUDAMED0320502004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063539 EUDAMED06975984063546 EUDAMED
- Basic UDI-DI
- B-06975984063539 EUDAMEDB-06975984063546 EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER 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
Serum Amyloid A (eCLIA) by Shenzhen Lifotronic Technology 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-06975984063539 | 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 bd8c66cc-0086-4828-9601-68fdddd24250 61 fields · synced Jul 21, 2026
- EUDAMED 11df83ec-0b60-45bf-80a6-4b6dbb343961 61 fields · synced May 18, 2026