Ultrasound Gel Pad
by Shenzhen Rising Medical Co., Ltd 4 variants
Ref AKS-R90-15Model AKS-R90-10，AKS-R90-15，AKS-R90-20, AKS-80-120,AKS-X,AKS-Y,AKS-Z
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69277169008GEL003E4 06927716901435 | Date20 Oct 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- AKS-R90-10，AKS-R90-15，AKS-R90-20, AKS-80-120, AKS-X, AKS-Y, AKS-Z, AKS-R90-15
- Primary DI / UDI-DI
- 06927716901435
- Basic UDI-DI
- 69277169008GEL003E4
- EMDN Code
- Z11049085 Various ultrasound instruments - consumables
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000036422
- Authorised representative
- HyperCert Limited B.V. NL-AR-000047746
Other devices from Shenzhen Rising Medical Co., Ltd
Properties
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No