Portable DR Imaging System
EUDAMEDFDA UDIClass IIb (EU MDR)
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-2300 EUDAMEDFDA UDI
- Description
- Portable DR Imaging System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938396423018 EUDAMEDFDA UDI
- Basic UDI-DI
- 693839640030013XBL00000Y3 EUDAMED
- 510(k) Number
- K202353 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Stationary basic diagnostic x-ray system, digital
Portable DR Imaging System by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 55bffb15-9dd0-4b1a-9025-9566c3c156cd 61 fields · synced Jul 9, 2026
- FDA UDI 0a81493e-5ab0-4467-bb79-631fb6e29b4b 34 fields · synced May 30, 2026