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Pepsinogen Ⅰ Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2044E-100Ref S2044E-200Ref S2044E-75Ref S2044E-25
Identity
- Device Name
- Pepsinogen Ⅰ Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2044E-100 EUDAMEDS2044E-200 EUDAMEDS2044E-75 EUDAMEDS2044E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792739499 EUDAMED06955792739512 EUDAMED06955792739482 EUDAMED06955792739468 EUDAMED
- Basic UDI-DI
- B-06955792739499 EUDAMEDB-06955792739512 EUDAMEDB-06955792739482 EUDAMEDB-06955792739468 EUDAMED
- EMDN Code
- W0102069006 PEPSINOGEN 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
Pepsinogen Ⅰ Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06955792739499 | 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 (4)
- EUDAMED 94c2be68-575c-4207-8ddf-8656074f187e 61 fields · synced Aug 2, 2026
- EUDAMED f6549103-7ee7-43ec-a4e1-f7ad1fd091fb 61 fields · synced May 17, 2026
- EUDAMED 545cc860-cf25-4938-ad5f-044f02a48991 61 fields · synced May 17, 2026
- EUDAMED 4b3d3cbf-c52f-42b6-bcc8-4a71ea556c5f 61 fields · synced May 17, 2026