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Atellica IM NFL Quality Control (NfL QC)
EUDAMEDClass C (EU MDR)
Ref 11643634Model IVDR_67_TTN_DUB-C_C_REAG_sNfL Control
Identity
- Trade Name
- Atellica IM NFL Quality Control (NfL QC) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_C_REAG_sNfL Control EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_C_REAG_sNfL Control EUDAMED11643634 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414635460 EUDAMED
- Basic UDI-DI
- 0405686902257VQ EUDAMED
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
Atellica IM NFL Quality Control (NfL QC) 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 | 0405686902257VQ | 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 c872d3a1-e3db-4439-83d1-cc0d97afd991 61 fields · synced Jul 10, 2026