← Back to catalogue
myQA SRS Detector Cyberknife Edition
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SR01-100
Identity
- Trade Name
- myQA SRS Detector Cyberknife Edition EUDAMEDFDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- myQA SRS EUDAMEDmyQA SRS Cyberknife edition FDA UDI
- Model / Reference
- SR01-100 EUDAMEDE3070200 FDA UDI
- Description
- myQA SRS Cyberknife edition FDA UDI
Identifiers
- Catalog Number
- SR01-100 FDA UDI
- Primary DI / UDI-DI
- EIBAE30702000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EIBAMYQASRSE4 EUDAMED
- Direct Marketing DI
- EIBAE30701000 EUDAMED
- 510(k) Number
- K031634 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z119002 DOSIMETERS EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
myQA SRS Detector Cyberknife Edition by IBA Dosimetry 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 | ++EIBAMYQASRSE4 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
- EUDAMED SRN
- DE-MF-000006225
Sources (2)
- EUDAMED 0b694e33-d814-46bb-8755-204f2da10369 61 fields · synced Jun 18, 2026
- FDA UDI 1d74acb8-6c3b-4651-877e-0d09fd13e9bc 36 fields · synced May 30, 2026