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Atellica IM Hepatitis A Total Quality Control (aHAVT QC)
EUDAMEDClass B (EU MDR)
Ref 10995448Model IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC
Identity
- Trade Name
- Atellica IM Hepatitis A Total Quality Control (aHAVT QC) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC EUDAMED10995448 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414597782 EUDAMED
- Basic UDI-DI
- 0405686900759W7 EUDAMED
- EMDN Code
- W0105080802 HEPATITIS VIRUS CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class B 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 Hepatitis A Total Quality Control (aHAVT QC) by Siemens Healthcare Diagnostics — Class B — 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 | 0405686900759W7 | Class B | 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 f28e852b-757a-4d01-8998-223989fa87a0 61 fields · synced Jul 10, 2026