ZzzQuil
Ref ZQ-80826438Model 2000342 / 18-3365
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 | Number001727620003428X 08700216710398 | Date4 Sep 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- Withdrawn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
- Device Name
- ZQE Nasal Dilator Sleep Clear Ultra
- Model / Reference
- 2000342 / 18-3365, ZQ-80826438
- Primary DI / UDI-DI
- 08700216710398
- Basic UDI-DI
- 001727620003428X
- EMDN Code
- M0599 Medical plasters - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- US-MF-000008641
- Authorised representative
- Aso Europe BV NL-AR-000004377
Other devices from Aso LLC
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