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Digital Color Doppler Ultrasound Imaging Scanner
EUDAMEDClass IIa (EU MDR)
Ref Apogee 6800ProModel Apogee 6900, Apogee 6900Pro, Apogee 6900Ace, Apogee 6800, Apogee 6800Pro, Apogee 6800Ace, Apogee 5800, Apogee 5800Exp, Apogee 3800
Identity
- Device Name
- Digital Color Doppler Ultrasound Imaging Scanner EUDAMED
- Model / Reference
- Apogee 6900, Apogee 6900Pro, Apogee 6900Ace, Apogee 6800, Apogee 6800Pro, Apogee 6800Ace, Apogee 5800, Apogee 5800Exp, Apogee 3800 EUDAMEDApogee 6800Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396400170 EUDAMED
- Basic UDI-DI
- 69383964001001220500000LR 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 | 69383964001001220500000LR | 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 cf168c4a-3a68-483b-83cb-352e2df0f2f3 61 fields · synced Oct 6, 2026