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Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)
EUDAMEDClass IVD General (EU MDR)
Ref Calibrator：1mL×6(91021)Ref R1:60mL×2 R2:12mL×2(701)Ref Quality Control：1mL×2(92014)Ref R1:70mL×2 R2:14mL×2(700)Ref R1:25mL×4 R2:5mL×4(707)
Identity
- Trade Name
- Pepsinogen I (PG I) Test Kit (Immunoturbidimetric) EUDAMED
- Device Name
- Pepsinogen I (PG I) Test Kit (Immunoturbidimetric) EUDAMED
- Model / Reference
- Calibrator：1mL×6(91021) EUDAMEDR1:60mL×2 R2:12mL×2(701) EUDAMEDQuality Control：1mL×2(92014) EUDAMEDR1:70mL×2 R2:14mL×2(700) EUDAMEDR1:25mL×4 R2:5mL×4(707) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674867913 EUDAMED06971674866985 EUDAMED06971674868279 EUDAMED06936895301363 EUDAMED06971674867012 EUDAMED
- Basic UDI-DI
- B-06971674867913 EUDAMEDB-06971674866985 EUDAMEDB-06971674868279 EUDAMEDB-06936895301363 EUDAMEDB-06971674867012 EUDAMED
- EMDN Code
- W01010127 PEPSIN 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) Test Kit (Immunoturbidimetric) by Biobase Biodustry(Shandong) 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-06971674867913 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (5)
- EUDAMED a66f480f-9322-40a3-a099-c1ed3a19aef7 61 fields · synced Oct 6, 2026
- EUDAMED 8e2764c1-781d-467e-aaaf-8404a15e3f60 61 fields · synced May 17, 2026
- EUDAMED 44991f9f-b764-4361-a75d-53cdd81122fe 61 fields · synced May 18, 2026
- EUDAMED 37748cdb-6289-4d81-8af7-1da4707e8d9a 61 fields · synced May 18, 2026
- EUDAMED e6895a75-edba-4d9b-8faa-e8277792204b 61 fields · synced May 19, 2026