Data / Medical devices / United Kingdom / Medicina Ltd
Medicina Ltd: FDA-registered device maker in Blackrod Bolton, United Kingdom, 2 510(k) clearances
Medicina Ltd is registered with the FDA (registration 3008432385) in Blackrod Bolton, United Kingdom. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 27, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008432385
- Address
- Unit 2 Rivington View Business Park Station Road, Blackrod Bolton, United Kingdom, BL6 5BN
- Owner or operator
- Medicina Ltd (10048928)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer
- First device listed
- November 24, 2016
- Registered through
- 2026
- Brand names listed
- ACE Stopper & Dressing, Bottle Adapters, Medicina ENFit Disposable Enteral Syringe, Medicina ENFit Reusable Enteral Syringe, Medicina Silo Bag, Reusable oral syringes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Intestine | KGY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Complaint file establishment, Foreign private label distributor | accessdata.fda.gov |
| Protector, Ostomy | EXE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2021 | K203613 | ENFit Reusable Enteral Syringe | PNR | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
| June 28, 2021 | K203410 | ENFit Disposable Enteral Syringe | PNR | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 4, 2022 | 90849 | Class II | Ongoing | Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification | accessdata.fda.gov |
Compare with other makers
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of Bag, Intestine
- All makers of Protector, Ostomy
- All makers of Container, Liquid Medication, Graduated
- All makers of Dispenser, Liquid Medication
Updated October 20, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.