OXYGEN RESEARCH INSTITUTE LIMITED

FDA Device Registration & Listing · Galway, IE · Registration 3026199641

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
3026199641
FEI Number
3026199641
Entity Name
OXYGEN RESEARCH INSTITUTE LIMITED
City/State/Country
Galway, IE
Establishment Address
Loughwell, Moycullen, Galway H91 H4C1, IE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Oxygen Research Institute Limited (Owner Number: 10087852)
Owner / Operator Contact Address
Loughwell, Moycullen, Galway, IE-G H91 H4C1, IE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

3H Corporation Myotape Nose Strip JIANGSU YIZHENG CAREPRO MEDICAL INSTRUMENTS CO., LTD Contec Medical Systems Co. Ltd. waist support: SGKB009, Back Support JIANGSU YIZHENG CAREPRO MEDICAL INSTRUMENTS CO., LTD.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2023-04-27
DQA Oximeter Cardiovascular Class 2 870.2700 2024-12-27
ISR Band Or Belt, Pelvic Support Physical Medicine Class 1 890.3025 2025-03-26
LWF Dilator, Nasal Ear, Nose, Throat Class 1 874.3900 2026-02-07

Official Correspondent

Patrick McKeown

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Oxygen Research Institute Limited
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
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026199641. Last updated year: 2026. Please use registration number 3026199641 when referencing this establishment in official correspondence.
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