← Back to catalogue
Portable X-ray unit
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref SR-9100Model SR-8230, SR-8230S, SR-8210, SR-8210S, SR-8100, SR-8100S, SR-8000, SR-8000S, SR-9100, SR-9200, SR-9300
Identity
- Device Name
- Portable X-ray unit EUDAMED
- Model / Reference
- SR-8230, SR-8230S, SR-8210, SR-8210S, SR-8100, SR-8100S, SR-8000, SR-8000S, SR-9100, SR-9200, SR-9300 EUDAMEDSR-9100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396402327 EUDAMED
- Basic UDI-DI
- 693839640030023X4300000GB EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Portable X-ray unit by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200976 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 693839640030023X4300000GB | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000010834
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED eca84b52-cdce-433c-9598-cee24863c96b 61 fields · synced Oct 7, 2026
- FDA 510(k) K200976 1 fields · synced May 18, 2026