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N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kit (Chemiluminescen…
EUDAMEDClass IVD General (EU MDR)
Ref "REF: USIA00000083M, USIA00000084M"
Identity
- Device Name
- N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kit (Chemiluminescent Microparticle Immunoassay) EUDAMED
- Model / Reference
- "REF: USIA00000083M, USIA00000084M" EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6-88B2 EUDAMED
- Basic UDI-DI
- B-6-88B2 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kit (Chemiluminescen… by URIT Medical Electronic Co., Ltd. — Class IVD General — CE/MDR — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-6-88B2 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED eaaba166-4868-4eeb-a4ca-6a7de4162cb0-1 61 fields · synced Oct 6, 2026
- EUDAMED eaaba166-4868-4eeb-a4ca-6a7de4162cb0-2 61 fields · synced Jul 10, 2026