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PepsinogenⅡ (PGⅡ) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 25 Tests/Kit
Identity
- Trade Name
- PepsinogenⅡ (PGⅡ) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- PepsinogenⅡ (PGⅡ) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986814323 EUDAMED
- Basic UDI-DI
- B-06974986814323 EUDAMED
- EMDN Code
- W0102069006 PEPSINOGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
PepsinogenⅡ (PGⅡ) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock 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-06974986814323 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2bdcd423-9cc0-4edd-a84f-6773f1f7b4bc 61 fields · synced Oct 6, 2026