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Digital Color Doppler Ultrasound Imaging Scanner
EUDAMEDClass IIa (EU MDR)
Ref Apogee 6200ProModel 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 5300ProRef Apogee 4800Model Apogee 3900, Apogee 3900Pro, Apogee 3600Pro, Apogee 5500, Apogee 5300, Apogee 3600, Apogee 3900Ace, Apogee 3600Ace, Apogee 4500, Apogee 4800Ref A25ProModel A56Exp,A56,A56Pro,A56Lite,A52,A52Pro,A52Lite,A52Exp,A50,A50Pro,A50Lite,A50Exp,A36,A36Pro,A36Lite,A36Exp,A32,A32Pro,A32Lite,A32Exp,A30,A30Pro,A30Lite,A30Exp,A25,A25Pro,A25Lite,A25Exp,A22,A22Pro,A22Lite,A22Exp,A20,A20Pro,A20Lite,A20ExpRef A30Ref Apogee 1000AceModel Apogee 1000, Apogee 1100Diamond, Apogee 1100Lite, Apogee 1000Neo, Apogee 1000Lite, Apogee 1000Pro, Apogee 1000Ace, CTS-5500, CTS-6600, Apogee 2000Ref Apogee 3600AceRef Apogee 3600Ref A22ProRef A56ExpRef A52ExpRef CTS-4000Model CTS-5000, CTS-4000Ref Apogee 1100LiteRef A25Ref Apogee 6200AceRef A25ExpRef A30LiteRef A52ProRef A50LiteRef Apogee 6500AceRef Apogee 5300ProRef A56ProRef Apogee 5500ProRef Apogee 1100ExpModel Apogee 2300, Apogee 2300Pro, Apogee 2300Ace, Apogee 2100, Apogee 2100Plus, Apogee 1100, Apogee 1100Exp, Apogee 1200, Apogee 1100Neo, CTS-8800, CTS-7700Ref Apogee 6300AceRef Apogee 5800ExpModel Apogee 6900, Apogee 6900Pro, Apogee 6900Ace, Apogee 6800, Apogee 6800Pro, Apogee 6800Ace, Apogee 5800, Apogee 5800Exp, Apogee 3800Ref A25LiteRef Apogee 2000Ref A20LiteRef A36ProRef A32LiteRef Apogee 1000ProRef Apogee 6900AceRef A32ProRef A36LiteRef Apogee 4500Ref A50Ref Apogee 1100NeoRef Apogee 2300AceRef A50ExpRef A56Ref A52Ref A52LiteRef Apogee 3900AceRef Apogee 6900ProRef A36Ref Apogee 6800
Identity
- Device Name
- Digital Color Doppler Ultrasound Imaging Scanner EUDAMED
- 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 6200Pro EUDAMEDApogee 3900, Apogee 3900Pro, Apogee 3600Pro, Apogee 5500, Apogee 5300, Apogee 3600, Apogee 3900Ace, Apogee 3600Ace, Apogee 4500, Apogee 4800 EUDAMEDApogee 4800 EUDAMEDA56Exp,A56,A56Pro,A56Lite,A52,A52Pro,A52Lite,A52Exp,A50,A50Pro,A50Lite,A50Exp,A36,A36Pro,A36Lite,A36Exp,A32,A32Pro,A32Lite,A32Exp,A30,A30Pro,A30Lite,A30Exp,A25,A25Pro,A25Lite,A25Exp,A22,A22Pro,A22Lite,A22Exp,A20,A20Pro,A20Lite,A20Exp EUDAMEDA25Pro EUDAMEDA30 EUDAMEDApogee 1000, Apogee 1100Diamond, Apogee 1100Lite, Apogee 1000Neo, Apogee 1000Lite, Apogee 1000Pro, Apogee 1000Ace, CTS-5500, CTS-6600, Apogee 2000 EUDAMEDApogee 1000Ace EUDAMEDApogee 3600Ace EUDAMEDApogee 3600 EUDAMEDA22Pro EUDAMEDA56Exp EUDAMEDA52Exp EUDAMEDCTS-5000, CTS-4000 EUDAMEDCTS-4000 EUDAMEDApogee 1100Lite EUDAMEDA25 EUDAMEDApogee 6200Ace EUDAMEDA25Exp EUDAMEDA30Lite EUDAMEDA52Pro EUDAMEDA50Lite EUDAMEDApogee 6500Ace EUDAMEDApogee 5300Pro EUDAMEDA56Pro EUDAMEDApogee 5500Pro EUDAMEDApogee 2300, Apogee 2300Pro, Apogee 2300Ace, Apogee 2100, Apogee 2100Plus, Apogee 1100, Apogee 1100Exp, Apogee 1200, Apogee 1100Neo, CTS-8800, CTS-7700 EUDAMEDApogee 1100Exp EUDAMEDApogee 6300Ace EUDAMEDApogee 6900, Apogee 6900Pro, Apogee 6900Ace, Apogee 6800, Apogee 6800Pro, Apogee 6800Ace, Apogee 5800, Apogee 5800Exp, Apogee 3800 EUDAMEDApogee 5800Exp EUDAMEDA25Lite EUDAMEDApogee 2000 EUDAMEDA20Lite EUDAMEDA36Pro EUDAMEDA32Lite EUDAMEDApogee 1000Pro EUDAMEDApogee 6900Ace EUDAMEDA32Pro EUDAMEDA36Lite EUDAMEDApogee 4500 EUDAMEDA50 EUDAMEDApogee 1100Neo EUDAMEDApogee 2300Ace EUDAMEDA50Exp EUDAMEDA56 EUDAMEDA52 EUDAMEDA52Lite EUDAMEDApogee 3900Ace EUDAMEDApogee 6900Pro EUDAMEDA36 EUDAMEDApogee 6800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938396400286 EUDAMED06938396448004 EUDAMED06938396403669 EUDAMED06938396401689 EUDAMED06938396403577 EUDAMED06938396403553 EUDAMED06938396400231 EUDAMED06938396403867 EUDAMED06938396403614 EUDAMED06938396403799 EUDAMED06938396440008 EUDAMED06938396400156 EUDAMED06938396403652 EUDAMED06938396400699 EUDAMED06938396403683 EUDAMED06938396403690 EUDAMED06938396403775 EUDAMED06938396403751 EUDAMED06938396400712 EUDAMED06938396400071 EUDAMED06938396403829 EUDAMED06938396400057 EUDAMED06938396400149 EUDAMED06938396400705 EUDAMED06938396400460 EUDAMED06938396403676 EUDAMED06938396420000 EUDAMED06938396403638 EUDAMED06938396403157 EUDAMED06938396403720 EUDAMED06938396403560 EUDAMED06938396403508 EUDAMED06938396403713 EUDAMED06938396403744 EUDAMED06938396445003 EUDAMED06938396401696 EUDAMED06938396400163 EUDAMED06938396403478 EUDAMED06938396403218 EUDAMED06938396403812 EUDAMED06938396403768 EUDAMED06938396403782 EUDAMED06938396403546 EUDAMED06938396403485 EUDAMED06938396403133 EUDAMED06938396468002 EUDAMED
- Basic UDI-DI
- 6938396400112A6300000006Y EUDAMED69383964001001214100000LN EUDAMED693839640010012H1400000ZC EUDAMED69383964001002207300000PD EUDAMED69383964001001204200000LG EUDAMED6938396400122A2X0000000SM EUDAMED69383964001001220500000LR EUDAMED
- Direct Marketing DI
- 06938396400286 EUDAMED06938396400699 EUDAMED06938396400712 EUDAMED06938396400071 EUDAMED06938396400057 EUDAMED06938396400705 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 | 6938396400112A6300000006Y | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000010834
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (46)
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