Data / Medical devices / Sri Lanka
Medical device makers in Sri Lanka: 13 FDA-registered establishments
13 establishments in Sri Lanka are registered with the FDA to make medical devices for the US market, listing 41 device types. 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Sri LankaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Pad, Menstrual, Reusable | NUQ | 4 |
| Garment, Protective, For Incontinence | EYQ | 3 |
| Accessory, Surgical Apparel | LYU | 2 |
| Medical Glove, Specialty | LZC | 2 |
| Polymer Patient Examination Glove | LZA | 2 |
| Latex Patient Examination Glove | LYY | 2 |
| Cover, Shoe, Operating-Room | FXP | 1 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 1 |
| Tourniquet, Nonpneumatic | GAX | 1 |
| Cap, Surgical | FYF | 1 |
| Gown, Examination | FME | 1 |
| Laryngoscope, Rigid | CCW | 1 |
| Massager, Therapeutic, Electric | ISA | 1 |
| Tubing, Pressure And Accessories | BYX | 1 |
| Filter, Bacterial, Breathing-Circuit | CAH | 1 |
| Bag, Reservoir | BTC | 1 |
| Mask, Oxygen | BYG | 1 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 1 |
| Connector, Airway (Extension) | BZA | 1 |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 |
| Clip, Nose | BXJ | 1 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 |
| Cannula, Nasal, Oxygen | CAT | 1 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 |
| Mouthpiece, Breathing | BYP | 1 |
| Tubing, Noninvasive | GAZ | 1 |
| Tourniquet, Pneumatic | KCY | 1 |
| Surgeon'S Gloves | KGO | 1 |
| Exerciser, Non-Measuring | ION | 1 |
| Orthosis, Limb Brace | IQI | 1 |
| Device, Transfer, Patient, Manual | FMR | 1 |
| Orthosis, Sacroiliac, Soft | IPW | 1 |
| Shoe And Shoe Cover, Conductive | BWP | 1 |
| Meter, Peak Flow, Spirometry | BZH | 1 |
| Dam, Rubber | EIE | 1 |
| Components, Exercise | IOD | 1 |
| Lift, Patient, Non-Ac-Powered | FSA | 1 |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 |
| Sling, Arm, Overhead Supported | ILE | 1 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 |
Makers in Sri Lanka
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Ansell Lanka (pvt.), Ltd. | BIYAGAMA Gampaha, Sri Lanka | 4 | 15 | 0 | 0 | api.fda.gov |
| Midas Safety Lanka (private) Limited | AVISSAWELLA Western, Sri Lanka | 2 | 12 | 0 | 0 | api.fda.gov |
| Lalan Rubbers (pvt) Ltd. | Malwana Gampaha, Sri Lanka | 4 | 2 | 0 | 0 | api.fda.gov |
| Bondville (pvt) Ltd | Gonapola Kalutara, Sri Lanka | 1 | 0 | 0 | 0 | api.fda.gov |
| Brandix Apparel Pvt Ltd Koggala | KOGGALA Southern, Sri Lanka | 1 | 0 | 0 | 0 | api.fda.gov |
| Flexicare Lanka (Pvt) Ltd | Bandaragama Western, Sri Lanka | 17 | 0 | 0 | 0 | api.fda.gov |
| Mas Fabrics (pvt) Ltd | Thulhiriya Sabaragamuwa, Sri Lanka | 2 | 0 | 0 | 0 | api.fda.gov |
| MAS Intimates (Private) Limited | Rathmalana Colombo, Sri Lanka | 1 | 0 | 0 | 0 | api.fda.gov |
| Minra Garments (pvt) Ltd | Puttlam North Western, Sri Lanka | 5 | 0 | 0 | 0 | api.fda.gov |
| Quality Latex Products (pvt) Ltd | hanwella Western, Sri Lanka | 5 | 0 | 0 | 0 | api.fda.gov |
| Rhino Consultants And Facilitators | Wattala Gampaha, Sri Lanka | 3 | 0 | 0 | 0 | api.fda.gov |
| Unichela ( Pvt) Ltd | Koggala Galle, Sri Lanka | 2 | 0 | 0 | 0 | api.fda.gov |
| Unichela Pvt Ltd - Panadura | Panadura Kalutara, Sri Lanka | 3 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.