HS40
by Samsung Medison Co., Ltd 64 variants
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880972578USS001X6 | Date3 Nov 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ultrasound Scanner
- Primary DI / UDI-DI
- 08809944881339, 08809880021417, 08809944883852, 08809880021653, 08809944883128, 08800357332500, 08809944881674, 08800357333347, 08809880020977, 08809944883005, 08800357331961, 08809944882831, 08800357332623, 08809944881179, 08809880021844, 08809944881438, 08809944883623, 08800357331909, 08809880021837, 08809944878896, 08809944882954, 08800357333040, 08800357331602, 08809944882879, 08800357333224, 08809880021141, 08809880021202, 08809880022179, 08809944883517, 08800357333064, 08800357332982, 08809944882947, 08800357332265, 08809880022735, 08809944881513, 08809880021035, 08809880022674, 08800357332166, 08809880022018, 08809880022353, 08809944883210, 08809944883289, 08800357331329, 08800357331800, 08809944883296, 08800357332227, 08809880021240, 08809944883791, 08800357331428, 08809944883388, 08809880022841
- Basic UDI-DI
- 880972578USS001X6
- EMDN Code
- Z11040101 Internal ultrasound scanners
- Device Class
- Class IIa
- EU market of registration
- GreeceRomaniaNorthern IrelandGermany
Manufacturer details
- EUDAMED SRN
- KR-MF-000011620
- Authorised representative
- Samsung Electronics GmbH DE-AR-000007005
Other devices from Samsung Medison Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No