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myQA SRS Phantom Cyberknife Edition
EUDAMEDFDA UDIClass I (EU MDR)
Ref SR02-001
Identity
- Trade Name
- myQA SRS Phantom Cyberknife Edition EUDAMEDmyQA® SRS Phantom Cyberknife FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- myQA SRS Phantom EUDAMEDmyQA® SRS Phantom Cyberknife for myQA SRS detector for SRS and SBRT patient plan verification FDA UDI
- Model / Reference
- SR02-001 EUDAMEDSR02001 FDA UDI
- Description
- myQA® SRS Phantom Cyberknife for myQA SRS detector for SRS and SBRT patient plan verification FDA UDI
Identifiers
- Catalog Number
- SR02-001 FDA UDI
- Primary DI / UDI-DI
- EIBASR020010 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EIBAMYQASRSPHANTOMXN EUDAMED
- Direct Marketing DI
- EIBASR020010 EUDAMED
- FDA Product Code
- IXG FDA UDI
- EMDN Code
- Z119002 DOSIMETERS EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1950 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
myQA SRS Phantom Cyberknife Edition by IBA Dosimetry GmbH — Class I — 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 | ++EIBAMYQASRSPHANTOMXN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
- EUDAMED SRN
- DE-MF-000006225
Sources (2)
- EUDAMED bd02d850-2bf5-4397-8aaf-9cb798b3853a 61 fields · synced Oct 5, 2026
- FDA UDI 0c54a3f2-6c1f-4768-bc73-f0c36457f0c9 35 fields · synced May 30, 2026