Identity
- Trade Name
- QA BeamChecker Pro EUDAMED
- Device Name
- QA Beam Analyzer EUDAMED
- Model / Reference
- 90503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850019946697 EUDAMED
- Basic UDI-DI
- 0850019946QACHECKER94 EUDAMED
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
QA BeamChecker Pro by Standard Imaging, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850019946QACHECKER94 | Class I | Active |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
- EUDAMED SRN
- US-MF-000009855
- Authorised Representative
- Hoff & Lowendahl AB SE-AR-000001888
Sources (1)
- EUDAMED e3c9abe9-f3e8-4746-a11c-1b7dd1333621 61 fields · synced Jul 17, 2026