Pocket Ultrasound System
by WuHan Youkey Bio-Medical Electronics Co., Ltd. 2 variants
Ref Included are following Pocket Ultrasound Probes (model: C5-2Ks, C5-2Fs, L11-4Ks, L11-4Gs, C8-5Ks, E10-4KsModel Q7, Q7(Included are following Pocket Ultrasound Probes (model: C5-2Ks, C5-2Fs, L11-4Ks, L11-4Gs, C8-5Ks, E10-4Ks))
Active
CE MDD
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/MDD | NumberB-06977793420015 06977793420015 | Date27 Mar 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- Q7, Included are following Pocket Ultrasound Probes (model: C5-2Ks, C5-2Fs, L11-4Ks, L11-4Gs, C8-5Ks, E10-4Ks, Q7(Included are following Pocket Ultrasound Probes (model: C5-2Ks, E10-4Ks))
- Primary DI / UDI-DI
- 06977793420015
- Basic UDI-DI
- B-06977793420015, 6977793421000Q767
- Direct Marketing DI
- 06977793420015
- EMDN Code
- Z11040103 Portable ultrasound scanners
- Device Class
- Class IIa
- EU market of registration
- GermanyItaly
Manufacturer details
- EUDAMED SRN
- CN-MF-000036468
- Authorised representative
- Share info GmbH DE-AR-000005132
Other devices from WuHan Youkey Bio-Medical Electronics Co., Ltd.
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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