Data / Medical devices / Malaysia / Vital Healthcare Sdn. Bhd.
Vital Healthcare Sdn. Bhd.: FDA-registered device maker in Kapar Selangor, Malaysia, 1 510(k) clearance
Vital Healthcare Sdn. Bhd. is registered with the FDA (registration 3044744771) in Kapar Selangor, Malaysia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3044744771
- Address
- PT 83718, Jalan Bestari 1A/KU7, Taman Perindustrian Kapar Bestari, Kapar Selangor, Malaysia, 42200
- Owner or operator
- Vital Healthcare Sdn. Bhd. (10092848)
- Roles
- Manufacturer
- First device listed
- April 9, 2026
- Registered through
- 2027
- Brand names listed
- VITAL Tubing Sets for Hemodialysis
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 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 |
|---|---|---|---|---|---|---|
| January 16, 2026 | K251341 | VITAL Tubing Sets for Hemodialysis | FJK | Substantially Equivalent | Vital Healthcare Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated January 16, 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.