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ARTIS pheno
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 10849000Model MDR_01_IIb_FOR_ACDV_ARTIS icono/pheno
Identity
- Trade Name
- ARTIS pheno EUDAMEDFDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- MDR_01_IIb_FOR_ACDV_ARTIS icono/pheno EUDAMED
- Model / Reference
- MDR_01_IIb_FOR_ACDV_ARTIS icono/pheno EUDAMED10849000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869046877 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900146UY EUDAMED
- FDA Product Code
- OWB FDA UDIJAA FDA UDI
- EMDN Code
- Z11030102 STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES EUDAMED
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ARTIS pheno by Siemens Healthcare GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0405686900146UY | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
- EUDAMED SRN
- DE-MF-000006122
Sources (2)
- EUDAMED 7c706129-bf70-4de0-bbb5-261f999f1318 61 fields · synced Oct 7, 2026
- FDA UDI e4f608e7-5db0-4af9-8a95-0aeaad0b0a50 35 fields · synced May 30, 2026