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Pepsinogen II Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass B (EU MDR)
Ref P13002Model 25 tests/box
Identity
- Trade Name
- Pepsinogen II Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Pepsinogen II Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP13002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580613 EUDAMED
- Basic UDI-DI
- 697518250P130025U EUDAMED
- Direct Marketing DI
- 06942293580613 EUDAMED
- EMDN Code
- W0102069006 PEPSINOGEN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
Yes
EUDAMED
Pepsinogen II Determination Kit (Fluorescence Immunochromatographic Assay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P130025U | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED cce9f9b7-21c0-4fe6-bf90-1ef111a0dc20 61 fields · synced Jun 18, 2026