Quest Products LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000014101
- Devices
- 10
- Registrations
- EUDAMED
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- Obelis S.A.BE
What Quest Products LLC makes
Quest Products LLC manufactures oral hygiene products, including XyliMelts lozenges and OraCoat XyliMelts oral coatings designed for oral care and throat relief. These products are formulated for self-administered use in managing oral health and discomfort.
The company’s portfolio is classified under Class I medical devices and is registered in the EU’s eudamed database. Quest Products LLC is based in the United States.
Catalogue
OraCoat XyliMelts Ref 1230000169028
Regimes: CE MDR Registry: EUDAMEDXyliMelts Ref ORA91079
Regimes: CE MDR Registry: EUDAMEDXyliMelts Ref ORA00821
Regimes: CE MDR Registry: EUDAMEDXyliMelts Ref ORA91088
Regimes: CE MDR Registry: EUDAMEDXyliMelts Ref ORA00210
Regimes: CE MDR Registry: EUDAMEDXyliMelts - DACH Ref ORA00777
Regimes: CE MDR Registry: EUDAMEDOraCoat XyliMelts Ref 01230000169011
Regimes: CE MDR Registry: EUDAMEDXyliMelts Ref ORA91083
Regimes: CE MDR Registry: EUDAMEDXyliMelts Ref ORA00361
Regimes: CE MDR Registry: EUDAMEDXyliMelts Ref ORA91082
Regimes: CE MDR CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000014101
- EU VAT number
- 36-4453415
- EUDAMED status
- Active
- EUDAMED registered name
- Quest Products LLC
- EUDAMED abbreviated name
- Quest
- Registered address
- 8201, 104th Street, 53158, Pleasant Prairie, United States
- Website
- www.QuestProductsInc.com
- [email protected]
- Phone
- +1 541-926-4577
- PRRC contact
- Jeff Haley
FDA recalls
FDA recall records list 1 recall initiated by Quest Products LLC, initiated on 2008-11-07. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 7 Nov 2008 Z-0968-2010 Unclassified (pre-2012) Terminated The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA.
From the company website
Innovative Self-Care Solutions. Helping people take charge of their health. Quest Products creates healthcare brands inspired by the power of self-care. Our Brands Alocane beWELL Clinere CopperFixx Enemeez OraCoat ProVent SunBurnt Tecnu LiceFreee!
Frequently asked questions
How many devices does Quest Products LLC have in the registry?
The registry currently lists 10 devices for Quest Products LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quest Products LLC's devices?
Among its 10 most recently registered devices, Quest Products LLC has devices listed in EUDAMED (10 devices).
What risk classes do Quest Products LLC's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Quest Products LLC's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Quest Products LLC?
FDA recall records list 1 recall initiated by Quest Products LLC, the most recent initiated on 7 Nov 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Quest Products LLC in the registry?
The most recently registered devices listed for Quest Products LLC include OraCoat XyliMelts, XyliMelts and XyliMelts - DACH.