FDA Registration
Active
🇬🇧 United Kingdom
MEDICINA LTD
Reg #: 3008432385
·
FEI: 3008432385
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- MEDICINA LTD
- Registration Number
- 3008432385
- FEI Number
- 3008432385
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 2 Rivington View Business Park, Station Road
- City
- Blackrod Bolton
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K203613
Owner / Operator
- Firm Name
- Medicina Ltd
- Operator Number
- 10048928
- Address
- Unit 2 Rivington View Business Park, Station Road
- City
- Blackrod
- State
- Bolton
- Postal Code
- BL6 5BN
- Country
- GB
- Correspondent
- Tracey J Macdonald
US Agent
- Business Name
- Marian Medical, Inc.
- Contact Name
- Sandy Winkler
- Address
- 3600 Chamberlain Ln 106
- City
- Louisville
- State
- KY
- ZIP
- 40241
- Country
- US
- [email protected]
- Phone
- 502 4256363 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2016-11-24 |
| Enteral Syringes With Enteral Specific Connectors | PNR | Class 2 | Gastroenterology, Urology | No | 2023-06-12 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2019-05-01 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2018-06-26 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2018-04-19 |
Proprietary Names
ACE Stopper & Dressing
Medicina ENFit Reusable Enteral Syringe
Medicina Silo Bag
Medicina ENFit Disposable Enteral Syringe
Reusable oral syringes
Bottle Adapters
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device