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Portable X-ray unit
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref SR-8100Model SR-8230, SR-8230S, SR-8210, SR-8210S, SR-8100, SR-8100S, SR-8000, SR-8000S, SR-9100, SR-9200, SR-9300
Identity
- Trade Name
- SIUI FDA UDI
- Generic Name
- Diagnostic x-ray system generator, portable FDA UDI
- Device Name
- Portable X-ray unit EUDAMEDFDA UDI
- 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-8100 EUDAMEDFDA UDI
- Description
- Portable X-ray Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938396481001 EUDAMEDFDA UDI
- Basic UDI-DI
- 693839640030023X4300000GB EUDAMED
- 510(k) Number
- K200637 FDA UDI
- FDA Product Code
- IZL FDA UDI
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
- GMDN Term
- Diagnostic x-ray system generator, portable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1720 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
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Portable X-ray unit by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K200637 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 693839640030023X4300000GB | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010834
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 99504419-a63e-4569-9459-f75e28a55c74 61 fields · synced Oct 7, 2026
- FDA UDI 551d9b0c-39c5-4d39-9a65-c603b01330fe 34 fields · synced May 30, 2026
- FDA 510(k) K200637 1 fields · synced May 18, 2026