Identity
- Trade Name
- Quicktome EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Quicktome EUDAMED
- Model / Reference
- SCI0001 EUDAMED1.2 FDA UDI
Identifiers
- Catalog Number
- SCI0001 FDA UDI
- Primary DI / UDI-DI
- 09358140000024 EUDAMEDFDA UDI
- Basic UDI-DI
- 935814000001CQ EUDAMED
- Direct Marketing DI
- 09358140000024 EUDAMED
- 510(k) Number
- K203518 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z12109092 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Quicktome by Omniscient Neurotechnology Pty Ltd — 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 | 935814000001CQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Omniscient Neurotechnology Pty Ltd
- EUDAMED SRN
- AU-MF-000023655
- Authorised Representative
- Freyr Life Sciences GmbH DE-AR-000021795
Sources (2)
- EUDAMED 45c48236-8049-47ad-9d14-7b257142ccb6 61 fields · synced Jul 22, 2026
- FDA UDI b7ade339-6275-4d19-b74a-32f4aa6362d2 34 fields · synced May 29, 2026