Medical Trolley
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- SIUI FDA UDI
- Generic Name
- Instrument trolley FDA UDI
- Device Name
- Medical Trolley EUDAMEDCR Series Trolley, CR Series Cart, used to transport medical ultrasound machines. FDA UDI
- Model / Reference
- CR-11/CR-12/CR-15/CR-20/CR-30A/CR-30B EUDAMEDCR-30A EUDAMEDFDA UDI
- Description
- CR Series Trolley, CR Series Cart, used to transport medical ultrasound machines. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938396497002 EUDAMEDFDA UDI
- Basic UDI-DI
- 6938396400131C30A000000EP EUDAMED
- Direct Marketing DI
- 06938396497002 EUDAMED
- FDA Product Code
- BZN FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Instrument trolley FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6175 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
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Medical Trolley by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 6938396400131C30A000000EP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 94edc1ba-e959-4fad-b6dc-d9a65db911da 61 fields · synced Oct 6, 2026
- FDA UDI b59476d6-292e-4df6-9a37-8d69b84e4213 33 fields · synced May 30, 2026