FDA Registration
Active
🇮🇪 Ireland
OXYGEN RESEARCH INSTITUTE LIMITED
Reg #: 3026199641
·
FEI: 3026199641
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OXYGEN RESEARCH INSTITUTE LIMITED
- Registration Number
- 3026199641
- FEI Number
- 3026199641
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Loughwell, Moycullen
- City
- Galway
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K082641
Owner / Operator
- Firm Name
- Oxygen Research Institute Limited
- Operator Number
- 10087852
- Address
- Loughwell, Moycullen
- City
- Galway
- State
- IE-G
- Postal Code
- H91 H4C1
- Country
- IE
- Correspondent
- Patrick McKeown
US Agent
- Business Name
- FDAbasics
- Contact Name
- Emily Matorin
- Address
- 1 Prospect Park West Ste 4D
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-04-27 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-12-27 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2025-03-26 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2026-02-07 |
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.
Establishment Types
Export Device to the United States But Perform No Other Operation on Device