Data / Medical devices / United Kingdom / Nuline Medical
Nuline Medical: FDA-registered device maker in Patna South Ayrshire, United Kingdom, 3 510(k) clearances
Nuline Medical is registered with the FDA (registration 3015633688) in Patna South Ayrshire, United Kingdom. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 24, 2007. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015633688
- Address
- Nuline Medical Limited Doonview, Patna South Ayrshire, United Kingdom, KA6 7JW
- Owner or operator
- Nuline Limited (10061624)
- Roles
- Manufacturer
- First device listed
- November 6, 2019
- Registered through
- 2027
- Brand names listed
- Ophthalmic patient drape, Surgical Gown, Surgical accessory, Surgical drape, Surgical mask, wrap for sterilisation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Patient, Ophthalmic | HMT | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 24, 2007 | K070431 | WELMED, INC. SURGICAL GOWNS | FYA | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| November 17, 1988 | K883827 | MASKS, VARIOUS TYPES OF SURGICAL MASKS | FXX | Substantially Equivalent | Greene International Corp. | accessdata.fda.gov |
| August 10, 1978 | K781301 | WRAP, STERILIZATION | FRG | Substantially Equivalent | Stanford Professional Products | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Patient, Ophthalmic
- All makers of Wrap, Sterilization
- All makers of Mask, Surgical
- All makers of Drape, Surgical, Exempt
- All makers of Accessory, Surgical Apparel
- All makers of Gown, Surgical
Updated May 24, 2007. 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.