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Digital Color Doppler Ultrasound Imaging Scanner
EUDAMEDClass IIa (EU MDR)
Ref Apogee 3600ProModel Apogee 3900, Apogee 3900Pro, Apogee 3600Pro, Apogee 5500, Apogee 5300, Apogee 3600, Apogee 3900Ace, Apogee 3600Ace, Apogee 4500, Apogee 4800
Identity
- Device Name
- Digital Color Doppler Ultrasound Imaging Scanner EUDAMED
- Model / Reference
- Apogee 3900, Apogee 3900Pro, Apogee 3600Pro, Apogee 5500, Apogee 5300, Apogee 3600, Apogee 3900Ace, Apogee 3600Ace, Apogee 4500, Apogee 4800 EUDAMEDApogee 3600Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396403539 EUDAMED
- Basic UDI-DI
- 69383964001001214100000LN 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 | 69383964001001214100000LN | 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 a7f14491-c351-4166-abdd-ef2a39bf5393 61 fields · synced Oct 8, 2026