Identity
- Trade Name
- ASiR-V EUDAMEDFDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- ASiR-V EUDAMEDASiR-V Application Container for Smart Subscription FDA UDI
- Model / Reference
- 5869273 EUDAMED1.1 FDA UDI
- Description
- ASiR-V Application Container for Smart Subscription FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278303196 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00155HA EUDAMED
- 510(k) Number
- K133640 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ASiR-V by GE Healthcare Japan Corporation — Class IIa — 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 | 8406821BUG00155HA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Japan Corporation
- EUDAMED SRN
- JP-MF-000009291
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 0ecfc7b7-79b6-4482-bd2c-7e5c68795eb7 61 fields · synced Jun 20, 2026
- FDA UDI 26761e24-0005-4b7c-b348-2b10a9a408ac 34 fields · synced May 30, 2026
- EUDAMED ed9e62bc-0b90-48fc-a0a8-e728af33653f 61 fields · synced Jun 20, 2026