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Atellica HEMA WBC DIFF
EUDAMEDClass A (EU MDR)
Ref 11374305Model IVDR_27_TTN_DUB-C_A_REAG_HEMA WBC Diff
Identity
- Trade Name
- Atellica HEMA WBC DIFF EUDAMED
- Device Name
- IVDR_27_TTN_DUB-C_A_REAG_HEMA WBC Diff EUDAMED
- Model / Reference
- IVDR_27_TTN_DUB-C_A_REAG_HEMA WBC Diff EUDAMED11374305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414289977 EUDAMED
- Basic UDI-DI
- 0405686902333VF EUDAMED
- Unit of Use DI
- 00630414323985 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 HEMA WBC DIFF by Siemens Healthcare Diagnostics — Class A — 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 | 0405686902333VF | Class A | 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 29a29504-ba4b-4fc4-9101-78e821a152d0 61 fields · synced Jun 19, 2026