ROCKFIELD MEDICAL DEVICES LTD.

FDA Device Registration & Listing · Galway, IE · Registration 3017607339

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017607339
FEI Number
3017607339
Entity Name
ROCKFIELD MEDICAL DEVICES LTD.
City/State/Country
Galway, IE
Establishment Address
ATU iHub Galway, Old Dublin Road, Galway H91 DCH9, IE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Rockfield Medical Devices Ltd (Owner Number: 10087042)
Owner / Operator Contact Address
ATU iHub Galway, Old Dublin Road, Galway, IE-G H91 DCH9, IE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222678
PMA Number
N/A

All Registered Proprietary Names

Mobility+ Enteral Feeding System OTC Mobility+ Enteral Feeding System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-06-26
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2024-06-26
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2023-01-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2023-01-05

Official Correspondent

Orla Connaughton

US Agent Details

Tom Dold Business: Vista Regulatory Solutions LLC Email: tdold@vistareg.com Phone: (612) 9656057

Related Public Records

Same Entity

Rockfield Medical Devices Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21
K872921 Medical Support, Inc. MSS ENTERAL DELIVERY SET 1987-12-03
K180622 Covidien Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port 2018-10-23

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3009247326 Jabil Circuit (Singapore) Pte Ltd Singapore Central Singapore, SG
2528981 LYNX Medical Pennsylvania ERIE, PA, US
1649518 Sterigenics US LLC Fort Worth, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017607339. Last updated year: 2026. Please use registration number 3017607339 when referencing this establishment in official correspondence.
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