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Digital Color Doppler Ultrasound Imaging Scanner
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
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Identity
- Trade Name
- SIUI FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Digital Color Doppler Ultrasound Imaging Scanner EUDAMEDDigital Color Doppler Ultrasound Imaging System FDA UDI
- Model / Reference
- Apogee 6500/Apogee 6300/Apogee 6200/Apogee 6500Pro/Apogee 6300Pro/Apogee 6200Pro/Apogee 6500Ace/Apogee 6300Ace/Apogee 6200Ace/Apogee 5500Exp/Apogee 5500Pro/Apogee 5300Neo/Apogee 5300Pro EUDAMEDApogee 6500 EUDAMEDFDA UDI
- Description
- Digital Color Doppler Ultrasound Imaging System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938396465001 EUDAMEDFDA UDI
- Basic UDI-DI
- 6938396400112A6300000006Y EUDAMED
- Direct Marketing DI
- 06938396465001 EUDAMED
- 510(k) Number
- K210318 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDI
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
MR Unsafe FDA UDI
Digital Color Doppler Ultrasound Imaging Scanner by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA…
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 | K210318 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6938396400112A6300000006Y | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010834
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 30d1c7dd-f629-49be-b77a-7627a43cf5ba 61 fields · synced Oct 6, 2026
- FDA UDI 2a77aacf-7c15-4c71-93e0-cff676fb6bb2 34 fields · synced May 30, 2026
- FDA 510(k) K210318 1 fields · synced May 18, 2026