Identity
- Trade Name
- myQA SRS Phantom² EUDAMEDmyQA® SRS Phantom FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- myQA SRS Phantom EUDAMEDmyQA® SRS Phantom for myQA SRS detector for SRS and SBRT patient plan verification FDA UDI
- Model / Reference
- SR02-002 EUDAMEDSR02-000 FDA UDI
- Description
- myQA® SRS Phantom for myQA SRS detector for SRS and SBRT patient plan verification FDA UDI
Identifiers
- Primary DI / UDI-DI
- EIBASR020000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EIBAMYQASRSPHANTOMXN EUDAMED
- Direct Marketing DI
- EIBASR020020 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 Phantom² 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 00c604e0-4937-4021-9a52-772a6be1fc42 61 fields · synced Jun 19, 2026
- FDA UDI 435e0023-fd4f-42a4-a7b3-bb690a08ae9f 34 fields · synced May 30, 2026