Identity
- Trade Name
- MatriXX Resolution EUDAMEDFDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- MatriXX Resolution EUDAMEDMatriXX Resolution - wireless detector f. rotational & static plan verification FDA UDI
- Model / Reference
- BS60-700 EUDAMEDE3063300 FDA UDI
- Description
- MatriXX Resolution - wireless detector f. rotational & static plan verification FDA UDI
Identifiers
- Primary DI / UDI-DI
- EIBAE30633000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EIBAMATRIXXRESOLUTIONAN EUDAMED
- Direct Marketing DI
- EIBAE30633000 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
MatriXX Resolution 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 | ++EIBAMATRIXXRESOLUTIONAN | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
- EUDAMED SRN
- DE-MF-000006225
Sources (2)
- EUDAMED a4e0e89e-53ac-4c2c-9516-4c61325d622c 61 fields · synced Jun 18, 2026
- FDA UDI 3b5e6cef-85b7-41f0-95c2-5a5e4d84cdf5 35 fields · synced May 30, 2026