Medicina Ltd
Blackrod Bolton, GB
MEDICINA LTD appears in FDA device records in Blackrod Bolton, GB. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Medicina Ltd carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medicina Uk Ltdenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008432385 | 3008432385 | MEDICINA LTD | Unit 2 Rivington View Business Park, Blackrod Bolton BL6 5BN GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0114-2023 | Medicina Reusable Oral syringe 2.5ml Code: OTH25 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification | Class II | Open, Classified | |
| Z-0113-2023 | Medicina Reusable Oral syringe 5ml Code: OTH05 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification | Class II | Open, Classified | |
| Z-0112-2023 | Medicina Reusable Oral syringe 1ml Code: OTH01 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification | Class II | Open, Classified | |
| Z-0111-2023 | Medicina Oral Tip Syringe 2.5ml Code: OT25 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification | Class II | Open, Classified | |
| Z-0110-2023 | Medicina Oral Tip Syringe 1ml Code: OT01 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification | Class II | Open, Classified | |
| Z-0109-2023 | Medicina Oral Tip Syringe 0.5ml Code: OT005 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification | Class II | Open, Classified | |
| Z-0108-2023 | Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification | Class II | Open, Classified | |
| Z-0107-2023 | 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 | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain