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Procalcitonin (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 689014Model 2×100T
Identity
- Trade Name
- Procalcitonin (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Procalcitonin (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×100T EUDAMED689014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341681005 EUDAMED
- Basic UDI-DI
- B-06970341681005 EUDAMED69703416803205004J3 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Procalcitonin (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-06970341681005 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341681005 | 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 29bd63f9-78fc-408f-9497-2f87b5cdfea1 61 fields · synced Jul 11, 2026
- EUDAMED 4a3c5cc6-cf73-4a67-ac7d-56e983bc252f 61 fields · synced May 19, 2026