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Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2143E-200Ref S2143E-100Ref S2143E-25Ref S2143E-150
Identity
- Device Name
- Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2143E-200 EUDAMEDS2143E-100 EUDAMEDS2143E-25 EUDAMEDS2143E-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742437 EUDAMED06955792742413 EUDAMED06955792742383 EUDAMED06955792742420 EUDAMED
- Basic UDI-DI
- B-06955792742437 EUDAMEDB-06955792742413 EUDAMEDB-06955792742383 EUDAMEDB-06955792742420 EUDAMED
- EMDN Code
- W0102060312 PARATHYROID HORMONE INTACT 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
Intact Parathyroid Hormone 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-06955792742437 | 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 1593aecf-21c6-4e6b-a987-9f03ff8d5908 61 fields · synced Oct 6, 2026
- EUDAMED 206616d4-c9bc-486c-96b9-372610a2f873 61 fields · synced May 17, 2026
- EUDAMED ffaa86dd-6f67-4e46-ba66-144d1993bd8c 61 fields · synced May 18, 2026
- EUDAMED 446bc58a-7d84-4ed0-be6b-6750c31fbdc0 61 fields · synced May 19, 2026