FDA Registration
Active
🇬🇧 United Kingdom
GBUK GROUP LIMITED
Reg #: 3007441619
·
FEI: 3007441619
·
Expires 2026
Products
24
Proprietary Names
0
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- GBUK GROUP LIMITED
- Registration Number
- 3007441619
- FEI Number
- 3007441619
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Woodland House, Blackwood Hall Business Park, North Duffield
- City
- Selby North Yorkshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K183665
Owner / Operator
- Firm Name
- GBUK Group Limited
- Operator Number
- 10056284
- Address
- Woodland House, Blackwood Hall Business Park, North Duffield
- City
- Selby
- State
- North Yorkshire
- Postal Code
- YO8 5DD
- Country
- GB
- Correspondent
- Chloe Kelly
US Agent
- Business Name
- Brosseau Consulting LLC
- Contact Name
- Bryan Brosseau
- Address
- 2352 Kennesaw Oaks Trl Nw
- City
- Kennesaw
- State
- GA
- ZIP
- 30152
- Country
- US
- [email protected]
- Phone
- 404 6107215
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2019-03-07 |
| Tubeless Analysis, Gastric Acidity | JLL | Class 1 | Clinical Chemistry | No | 2019-01-18 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-04-16 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-04-16 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2021-04-16 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2019-12-02 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2019-12-02 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2024-10-22 |
| Enteral Specific Transition Connectors | PIO | Class 2 | Gastroenterology, Urology | No | 2022-12-01 |
| Sling, Overhead Suspension, Wheelchair | INE | Class 1 | Physical Medicine | No | 2020-10-20 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2020-06-29 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2021-02-02 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2019-12-20 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2021-04-19 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2019-07-05 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2017-11-24 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2018-02-01 |
| Filter, Conduction, Anesthetic | BSN | Class 2 | Anesthesiology | No | 2018-02-01 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2018-02-01 |
| Utensil, Eating | ILC | Class 1 | Physical Medicine | No | 2021-01-27 |
| Enteral Syringes With Enteral Specific Connectors | PNR | Class 2 | Gastroenterology, Urology | No | 2018-02-01 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2019-07-05 |
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2019-12-03 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2018-03-05 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device