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Digital Color Doppler Ultrasound Imaging Scanner
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Apogee 5500Model Apogee 3900, Apogee 3900Pro, Apogee 3600Pro, Apogee 5500, Apogee 5300, Apogee 3600, Apogee 3900Ace, Apogee 3600Ace, Apogee 4500, Apogee 4800
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 3900, Apogee 3900Pro, Apogee 3600Pro, Apogee 5500, Apogee 5300, Apogee 3600, Apogee 3900Ace, Apogee 3600Ace, Apogee 4500, Apogee 4800 EUDAMEDApogee 5500 EUDAMEDFDA UDI
- Description
- Digital Color Doppler Ultrasound Imaging System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938396455019 EUDAMEDFDA UDI
- Basic UDI-DI
- 69383964001001214100000LN EUDAMED
- 510(k) Number
- K160853 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
Digital Color Doppler Ultrasound Imaging Scanner by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69383964001001214100000LN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 6d25b145-7ce2-4056-bd53-d994f85247c1 61 fields · synced Oct 6, 2026
- FDA UDI 6f4c96f1-66fc-456e-8e5e-45ce92c95a68 34 fields · synced May 29, 2026