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Folate (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 694019Model 50TRef 694021Model 2×100TRef 694020Model 2×50T
Identity
- Trade Name
- Folate (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Folate (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50T EUDAMED694019 EUDAMED2×100T EUDAMED694021 EUDAMED2×50T EUDAMED694020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341688066 EUDAMED06970341681135 EUDAMED06975984063195 EUDAMED
- Basic UDI-DI
- B-06970341688066 EUDAMEDB-06970341681135 EUDAMEDB-06975984063195 EUDAMED
- EMDN Code
- W0102070103 FOLATE 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
Folate (Electrochemiluminescence 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-06970341688066 | 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 (3)
- EUDAMED 934dc71b-a208-4ce3-89bd-8e6e43304092 61 fields · synced Jul 27, 2026
- EUDAMED 57a4de4c-5af3-477f-a77e-2cf9ec10a2dc 61 fields · synced May 17, 2026
- EUDAMED 57a21034-a67b-412d-bcd3-5d0e09bf267d 61 fields · synced May 17, 2026