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Pepsinogen II (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 696026Model 2×50TRef 696025Model 50TRef 696022Model 2×100TRef 696021Model 100T
Identity
- Trade Name
- Pepsinogen II (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Pepsinogen II (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50T EUDAMED696026 EUDAMED50T EUDAMED696025 EUDAMED2×100T EUDAMED696022 EUDAMED100T EUDAMED696021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063058 EUDAMED06970341688103 EUDAMED06970341681043 EUDAMED06970341680633 EUDAMED
- Basic UDI-DI
- B-06975984063058 EUDAMEDB-06970341688103 EUDAMEDB-06970341681043 EUDAMEDB-06970341680633 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 II (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-06975984063058 | 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 (4)
- EUDAMED 969f7982-f741-4e43-a234-6c525e9f6119 61 fields · synced Sep 18, 2026
- EUDAMED 9425bd0b-434c-4630-a99d-3eedcc9a3a45 61 fields · synced May 16, 2026
- EUDAMED 457e06f5-ff0c-4bcb-baae-0f4337d49361 61 fields · synced May 17, 2026
- EUDAMED dd8aa268-dbff-4a5c-90fb-5c2329aa2257 61 fields · synced May 18, 2026