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Pepsinogen I (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 696023Model 50TRef 696011Model 100T
Identity
- Trade Name
- Pepsinogen I (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Pepsinogen I (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50T EUDAMED696023 EUDAMED100T EUDAMED696011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341688097 EUDAMED06970341680640 EUDAMED
- Basic UDI-DI
- B-06970341688097 EUDAMEDB-06970341680640 EUDAMED
- EMDN Code
- W0102069006 PEPSINOGEN 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
Pepsinogen I (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-06970341688097 | 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 a85e2671-8fff-4c06-9950-850b71916076 61 fields · synced Jul 13, 2026
- EUDAMED 8466d2a5-4f84-4081-84a9-77186457363f 61 fields · synced May 19, 2026