Data / Medical devices / Bangladesh
Medical device makers in Bangladesh: 11 FDA-registered establishments
11 establishments in Bangladesh are registered with the FDA to make medical devices for the US market, listing 43 device types. 1 has 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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- BangladeshCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Non-Surgical Gown | OEA | 5 |
| Accessory, Surgical Apparel | LYU | 4 |
| Cap, Surgical | FYF | 4 |
| Gown, Examination | FME | 4 |
| Cover, Shoe, Operating-Room | FXP | 3 |
| Bedding, Disposable, Medical | KME | 3 |
| Suit, Surgical | FXO | 3 |
| Splint, Hand, And Components | ILH | 2 |
| Dispenser, Solid Medication | NXB | 2 |
| Gown, Surgical | FYA | 2 |
| Dress, Surgical | FYE | 1 |
| Support, Patient Position | CCX | 1 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 |
| Pad, Eye | HMP | 1 |
| Drape, Surgical, Exempt | PUI | 1 |
| Pill Crusher/Cutter | OHY | 1 |
| Adaptor, Hygiene | ILS | 1 |
| Sling, Arm | ILI | 1 |
| Cover, Mattress (Medical Purposes) | FMW | 1 |
| Fiber, Medical, Absorbent | FRL | 1 |
| Applicator, Vaginal | HGD | 1 |
| Orthosis, Lumbar | IQE | 1 |
| Joint, Knee, External Brace | ITQ | 1 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | 1 |
| Bottle, Hot/Cold Water | FPF | 1 |
| Bag, Ice | KYR | 1 |
| Pack, Hot Or Cold, Reusable | IME | 1 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 |
| Orthosis, Limb Brace | IQI | 1 |
| Shoe, Cast | IPG | 1 |
| Douche Apparatus, Vaginal, Therapeutic | HED | 1 |
| Aid, Transfer | IKX | 1 |
| Spectacle, Magnifying | HOI | 1 |
| Frame, Spectacle | HQZ | 1 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 |
| Joint, Ankle, External Brace | ITW | 1 |
| Restraint, Protective | FMQ | 1 |
| Support, Arm | IOY | 1 |
| Orthosis, Corrective Shoe | KNP | 1 |
| Lift, Patient, Non-Ac-Powered | FSA | 1 |
| Binder, Abdominal | FSD | 1 |
| Attachment, Commode, Wheelchair | INB | 1 |
| Case, Contact Lens | LRX | 1 |
Makers in Bangladesh
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Shun Ho (bangladesh) Manufactory Limited | Cumilla Zilla Chittagong(Division), Bangladesh | 10 | 1 | 0 | 0 | api.fda.gov |
| Bay Footwear Limited | Gazipur Dhaka(Division), Bangladesh | 1 | 0 | 0 | 0 | api.fda.gov |
| Beximco Ppe Limited | Dhaka Dhaka(Division), Bangladesh | 7 | 0 | 0 | 0 | api.fda.gov |
| Hossain Dyeing & Printing Mills Ltd. | Gazipur Dhaka(Division), Bangladesh | 1 | 0 | 0 | 0 | api.fda.gov |
| Jiehong Medical Products(bangladesh) Co.ltd | Chattogram Chittagong(Division), Bangladesh | 8 | 0 | 0 | 0 | api.fda.gov |
| Jiehong Nonwoven Products(bd) Co.,ltd | Chattogram Chittagong(District), Bangladesh | 7 | 0 | 0 | 0 | api.fda.gov |
| Mazen (bangladesh) Industries Limited. | Uttara Export Processing Zone Nilphamari, Bangladesh | 4 | 0 | 0 | 0 | api.fda.gov |
| Operating Theatre Medical Bangladesh Company Limited | Kaliakair Gazipur, Bangladesh | 8 | 0 | 0 | 0 | api.fda.gov |
| Tung Hing (bangladesh) Manufactory Limited | Cumilla Chuadanga, Bangladesh | 2 | 0 | 0 | 0 | api.fda.gov |
| United Surgical, Ltd. | P.U. Kadda, Gazipur, Bangladesh | 14 | 0 | 0 | 0 | api.fda.gov |
| Wellmed Company Limited | Gazipur Sadar, Bangladesh | 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.