Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010162623

FEI Number

3010162623

Entity Name

LABORATOIRE UNITHER

City/State/Country

Amiens Cedex 2 Hauts-de-France, FR

Establishment Address

151 rue Andre Durouchez, Espace Industriel Nord, CS28028, Amiens Cedex 2 Hauts-de-France 80084, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Laboratoire Unither (Owner Number: 10042315)

Owner / Operator Contact Address

1 Rue de l Arquerie, Coutances, FR-NOR 50200, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2025-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

Danielle Seamon Business: Unither Manufacturing LLC Email: Danielle.seamon@unither-pharma.com Phone: (240) 3552253

Related Public Records

Same Entity

Laboratoire Unither

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010200303	Laboratoire Unither	Coutances Normandie, FR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010162623. Last updated year: 2026. Please use registration number 3010162623 when referencing this establishment in official correspondence.