QA BeamChecker Pro
Ref 90503
QA BeamChecker Pro (90503) is a Class I device made by Standard Imaging Inc., registered in EUDAMED on 16 May 2026 (Basic UDI-DI 0850019946QACHECKER94) with CE/MDR certificate 28620136130-01 valid until 18 Oct 2027, active as of 8 Nov 2026.
Expiring
CE MDR
Valid until
18 Oct 2027
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0850019946QACHECKER94 00850019946697 | Date16 May 2026 | StatusActive |
Official records
- EUDAMED public site 0850019946QACHECKER94
Certificates
- 28620136130-01 Expiring
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 22 Feb 2023
- Expires
- 18 Oct 2027
Timeline
- Certificate issued EUDAMED 28620136130-01
- Registered EUDAMED 0850019946QACHECKER94
- Certificate expires EUDAMED 28620136130-01
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device name
- QA Beam Analyzer
- Model / reference
- 90503
- Primary DI / UDI-DI
- 00850019946697
- Basic UDI-DI
- 0850019946QACHECKER94
- EMDN code
- Z11019099 Various radiotherapy and radiosurgery instruments - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000009855
- Authorised representative
- Hoff & Lowendahl AB SE-AR-000001888
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