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Pro-gastrin-releasing Peptide Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2050E-200Ref S2050E-100Ref S2050E-75
Identity
- Device Name
- Pro-gastrin-releasing Peptide Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2050E-200 EUDAMEDS2050E-100 EUDAMEDS2050E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739871 EUDAMED06955792739857 EUDAMED06955792739840 EUDAMED
- Basic UDI-DI
- B-06955792739871 EUDAMEDB-06955792739857 EUDAMEDB-06955792739840 EUDAMED
- EMDN Code
- W0102030121 PRO-GASTRIN-RELEASING PEPTIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Pro-gastrin-releasing Peptide Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792739871 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 744f9a20-2537-4000-8e4f-6a3e5d11153e 61 fields · synced Aug 2, 2026
- EUDAMED 119fde6b-056d-44d1-b2ef-133ce5828bf6 61 fields · synced May 17, 2026
- EUDAMED b4954d5a-5f3d-4a2d-82b9-2a0e61d0320a 61 fields · synced May 18, 2026