← Back to catalogue
Pepsinogen I (PG I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoa…
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/kit（DR1100-1）Model 50 Tests/kitRef 200 Tests/kit（DR1100-3）Model 200 Tests/kit
Identity
- Trade Name
- Pepsinogen I (PG I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Pepsinogen I (PG I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 50 Tests/kit EUDAMED50 Tests/kit（DR1100-1） EUDAMED200 Tests/kit EUDAMED200 Tests/kit（DR1100-3） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981400 EUDAMED06974969982544 EUDAMED
- Basic UDI-DI
- B-06974969981400 EUDAMEDB-06974969982544 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
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 I (PG I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoa… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969981400 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 245a3fdc-1ff3-424a-ae93-3caac0bcfb3e 61 fields · synced Oct 6, 2026
- EUDAMED e48754b6-3ed4-44f1-942c-803af4d17fd7 61 fields · synced May 19, 2026