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Atellica CH Alpha-1-antitrypsin 2 (AAT2)
EUDAMEDClass B (EU MDR)
Ref 11537578Model IVDR_67_TTN_DUB-C_B_REAG_AAT2
Identity
- Trade Name
- Atellica CH Alpha-1-antitrypsin 2 (AAT2) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_B_REAG_AAT2 EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_B_REAG_AAT2 EUDAMED11537578 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414653310 EUDAMED
- Basic UDI-DI
- 0405686902361VL EUDAMED
- Unit of Use DI
- 00630414321899 EUDAMED
- EMDN Code
- W0102019002 A1-ANTITRYPSIN (PROTEASE INHIBITOR) 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 CH Alpha-1-antitrypsin 2 (AAT2) 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 | 0405686902361VL | 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 b9b25a0b-af79-4213-a386-394c59473a56 61 fields · synced Jun 19, 2026