← Back to catalogue
Portable DR Imaging System
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref SR-300ProModel 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-100ProRef SR-1100ProRef SR-300Ref SR-200Ref SR-200ProRef SR-2000Ref SR-2300Pro
Identity
- Device Name
- Portable DR Imaging System EUDAMED
- 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-300Pro EUDAMEDSR-1100Pro EUDAMEDSR-300 EUDAMEDSR-200 EUDAMEDSR-200Pro EUDAMEDSR-2000 EUDAMEDSR-2300Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396401634 EUDAMED06938396401719 EUDAMED06938396401603 EUDAMED06938396401566 EUDAMED06938396401597 EUDAMED06938396401658 EUDAMED06938396410124 EUDAMED
- Basic UDI-DI
- 693839640030013XBL00000Y3 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY 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
Category: Stationary basic diagnostic x-ray system, digital
Portable DR Imaging System by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Similar devices
Also classified as Stationary basic diagnostic x-ray system, digital.
- EXSYS DEXi — Drtech Corp. · Class II
- DX-D 400 — Agfa Corp. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- CARESTREAM DRX-EVOLUTION — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- iDR603V-110 — YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD. · Class IIb
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 | K202353 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 693839640030013XBL00000Y3 | 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 (8)
- EUDAMED 60899436-d3f0-4da1-b3aa-31033a4fe983 61 fields · synced Jul 31, 2026
- EUDAMED ca23c9a7-029c-439c-bea5-53ef9520dc98 61 fields · synced May 11, 2026
- EUDAMED f1db8592-dfdd-417b-8ac8-095a4d92d856 61 fields · synced May 16, 2026
- EUDAMED 41c47507-d8b8-4d14-8d37-2f3122de573a 61 fields · synced May 16, 2026
- EUDAMED f54271fe-7929-4a50-b994-2b6af74d6053 61 fields · synced May 17, 2026
- EUDAMED 0f52964d-9532-46aa-ae04-0e92049c4f24 61 fields · synced May 17, 2026
- EUDAMED 7cee3cc4-700b-4f9d-93b3-5d40ddbb1d4c 61 fields · synced May 19, 2026
- FDA 510(k) K202353 1 fields · synced May 18, 2026