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Digital Color Doppler Ultrasound Imaging Scanner
EUDAMEDClass IIa (EU MDR)
Ref Apogee 2300ProModel Apogee 2300, Apogee 2300Pro, Apogee 2300Ace, Apogee 2100, Apogee 2100Plus, Apogee 1100, Apogee 1100Exp, Apogee 1200, Apogee 1100Neo, CTS-8800, CTS-7700
Identity
- Device Name
- Digital Color Doppler Ultrasound Imaging Scanner EUDAMED
- Model / Reference
- Apogee 2300, Apogee 2300Pro, Apogee 2300Ace, Apogee 2100, Apogee 2100Plus, Apogee 1100, Apogee 1100Exp, Apogee 1200, Apogee 1100Neo, CTS-8800, CTS-7700 EUDAMEDApogee 2300Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396401085 EUDAMED
- Basic UDI-DI
- 6938396400122A2X0000000SM EUDAMED
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Digital Color Doppler Ultrasound Imaging Scanner by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 6938396400122A2X0000000SM | 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 (1)
- EUDAMED 336fc074-d5f9-42f6-aa4e-aaa303a61c28 61 fields · synced Oct 7, 2026