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Magnetic Resonance Imaging System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 88002028Model uMR Ultra
Identity
- Trade Name
- uMR FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- Magnetic Resonance Imaging System EUDAMEDFDA UDI
- Model / Reference
- uMR Ultra EUDAMEDFDA UDI88002028 EUDAMED
- Description
- Magnetic Resonance Imaging System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576830527 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683052N7 EUDAMED
- 510(k) Number
- K243547 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z11050105 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T EUDAMED
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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
Yes
FDA UDI
Magnetic Resonance Imaging System by Shanghai United Imaging Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K243547 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697157683052N7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000008501
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 54b5a11a-aec4-48ab-b729-74057beccd69 61 fields · synced Oct 7, 2026
- FDA UDI 9b739c3d-5e85-469a-8fae-c97b8a0a6d93 35 fields · synced May 29, 2026
- FDA 510(k) K243547 1 fields · synced May 18, 2026