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Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 25 Tests/KitRef 100 Tests/Kit
Identity
- Trade Name
- Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED100 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986814309 EUDAMED06974986813074 EUDAMED
- Basic UDI-DI
- B-06974986814309 EUDAMEDB-06974986813074 EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER 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
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…
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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-06974986814309 | 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 (2)
- EUDAMED a4067f23-4544-430a-b238-a51ff2947abc 61 fields · synced Oct 6, 2026
- EUDAMED 3dc5ea71-b7fc-425c-8578-453700d5939f 61 fields · synced May 19, 2026