Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016629854

FEI Number

3016629854

Entity Name

HIDRAMED SOLUTIONS LIMITED

City/State/Country

Galway, IE

Establishment Address

Unit 209 Business Innovation Centre, NUI Galway, Galway H91V207, IE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HidraMed Solutions Limited (Owner Number: 10062420)

Owner / Operator Contact Address

Business Innovation Centre, NUI Galway, Galway, IE-G H91V207, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HidraWear BB GBB001_GBB002 HidraWear AX GAX001_GAX002

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2020-02-06

Official Correspondent

Conan Cavanagh

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

HidraMed Solutions Limited

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016629854. Last updated year: 2026. Please use registration number 3016629854 when referencing this establishment in official correspondence.