Saliva ejector (Surgical aspirator, suction tips)
by Faithful Medical (Hebei) Co., ltd
Ref FMES01MModel FMES01M, FMES02M, FMES03L, FMES03M, FMES03S, FMES04M
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 | Number698025124FMESH2 | Date13 Jul 2026 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Saliva ejector (Surgical aspirator, suction tips)
- Model / Reference
- FMES01M, FMES02M, FMES03L, FMES03M, FMES03S, FMES04M
- Primary DI / UDI-DI
- 06980251240988
- Basic UDI-DI
- 698025124FMESH2
- EMDN Code
- Q019001 Saliva aspirators and saliva absorbents
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000056876
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Faithful Medical (Hebei) 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