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Portable DR Imaging System
EUDAMEDClass IIb (EU MDR)
Ref SR-100Model 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
- 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-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396401528 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
Portable DR Imaging System by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 693839640030013XBL00000Y3 | 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 (1)
- EUDAMED 16edf772-3da6-4fda-b73b-565346b545d3 61 fields · synced Jun 18, 2026