Ear Syringes
by Hui Zhou Suan Technology Co., Limited 11 variants
Ref SA-N09Model SA-N01, SA-N02, SA-N03, SA-N04, SA-N05, SA-N06, SA-N07, SA-N08, SA-N09, SA-N10, SA-N11, SA-N12
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 | Number697620459ES01KU 06976204590217 | Date7 Aug 2024 | 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- Withdrawn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
- Device Name
- Ear Syringes
- Model / Reference
- SA-N01, SA-N02, SA-N03, SA-N04, SA-N05, SA-N06, SA-N07, SA-N08, SA-N09, SA-N10, SA-N11, SA-N12
- Primary DI / UDI-DI
- 06976204590217
- Basic UDI-DI
- 697620459ES01KU
- EMDN Code
- Q03040299 Ear irrigation devices - other
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000043037
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hui Zhou Suan Technology Co., Limited
See all devices from Hui Zhou Suan Technology Co., Limited →
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