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Pepsinogen II (PGII) Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32028066Model 100T/kitRef 32026066Model 25TRef 32027066Model 50T/kit
Identity
- Device Name
- Pepsinogen II (PGII) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 100T/kit EUDAMED32028066 EUDAMED25T EUDAMED32026066 EUDAMED50T/kit EUDAMED32027066 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334800675 EUDAMED06950334803652 EUDAMED06950334800668 EUDAMED
- Basic UDI-DI
- B-06950334800675 EUDAMEDB-06950334803652 EUDAMEDB-06950334800668 EUDAMED
- EMDN Code
- W0102069006 PEPSINOGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
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
Pepsinogen II (PGII) Detection Kit (Nephelometry) by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06950334800675 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 6ea01324-0ed0-46c6-b468-77975396fbf8 61 fields · synced Jul 17, 2026
- EUDAMED c6767a76-4779-48ad-8c40-54fa267e5e2e 61 fields · synced May 17, 2026
- EUDAMED 51f3a5ab-2fca-4062-81b1-3ce7c06f62b5 61 fields · synced May 19, 2026