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Atellica IM NT-proBNP (PBNP)
EUDAMEDClass C (EU MDR)
Ref 11200589Model IVDR_67_TTN_DUB-C_C_KIT_PBNP
Identity
- Trade Name
- Atellica IM NT-proBNP (PBNP) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_C_KIT_PBNP EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_C_KIT_PBNP EUDAMED11200589 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414228952 EUDAMED
- Basic UDI-DI
- 0405686901817W3 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
Atellica IM NT-proBNP (PBNP) by Siemens Healthcare Diagnostics — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0405686901817W3 | Class C | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- EUDAMED SRN
- US-MF-000016560
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (1)
- EUDAMED ac518f7c-6944-4112-9e93-cc209e19c346 61 fields · synced Jun 18, 2026