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Portable DR Imaging System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SR-1100Model SR-2300, SR-2300Pro, SR-2000, SR-200Pro, SR-1100, SR-1100Pro, SR-1000, SR-1000Pro, SR-300, SR-300Pro, SR-200, SR-100, SR-100Pro
Identity
- Trade Name
- SIUI FDA UDI
- Generic Name
- Portable basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Portable DR Imaging System EUDAMEDFDA UDI
- Model / Reference
- SR-2300, SR-2300Pro, SR-2000, SR-200Pro, SR-1100, SR-1100Pro, SR-1000, SR-1000Pro, SR-300, SR-300Pro, SR-200, SR-100, SR-100Pro EUDAMEDSR-1100 EUDAMEDFDA UDI
- Description
- Portable DR Imaging System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938396400415 EUDAMEDFDA UDI
- Basic UDI-DI
- 693839640030013XBL00000Y3 EUDAMED
- 510(k) Number
- K202350 FDA UDI
- FDA Product Code
- IZL FDA UDIMQB FDA UDILLZ FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Portable basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1720 FDA UDI892.1680 FDA UDI892.2050 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
No
FDA UDI
Combination Product
Yes
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 DR Imaging System by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 693839640030013XBL00000Y3 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010834
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 053298a0-f464-4e2d-97f8-7c57580032f5 61 fields · synced Oct 6, 2026
- FDA UDI 2a927841-19c3-4b92-a133-8700d8538b92 34 fields · synced May 30, 2026