XyliMelts
by Quest Products LLC 7 variants
Ref ORA91082, ORA91087, XyliMelts, ORA91044, ORA00354, ORA91043, ORA91045, ORA91080, ORA91081, ORA00814
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number855933000ORAPL | Date19 Apr 2023 | StatusActive |
| European Union | CE/MDR | Number855933000ORAPL | Date19 Apr 2023 | 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- Withdrawn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/MDD, CE/MDR Active
Specification
- Device Name
- OraCoat XyliMelts
- Model / Reference
- ORA91082, ORA91087, XyliMelts, ORA91044, ORA00354, ORA91043, ORA91045, ORA91080, ORA91081, ORA00814
- Primary DI / UDI-DI
- 00810037910827, 00810037910872, D-XyliMelts6E, 00810037910445, 00855933000746, 00810037910438, 00810037910452, 00810037910803, 00810037910810, 00855933000814
- Basic UDI-DI
- 855933000ORAPL, B-XyliMelts6E
- EMDN Code
- V9017 Oral administration preparations not included in other classes
- Device Class
- Class I
- EU market of registration
- CzechiaPortugalNorthern IrelandFranceNorwayItalyNetherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000014101
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Quest Products 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