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Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Imm…
EUDAMEDClass IVD General (EU MDR)
Ref DF1101Model 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2
Identity
- Trade Name
- Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2 EUDAMEDDF1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942028502286 EUDAMED
- Basic UDI-DI
- B-06942028502286 EUDAMED
- EMDN Code
- W0105010402 H. PYLORI ANTIBODY ASSAYS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Imm… by Sichuan Orienter Biotechnology Co., Ltd. — Class IVD General — IVDD…
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-06942028502286 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 781a217d-08e9-4345-955a-030b4b4f2c76 61 fields · synced Jul 9, 2026