Data / Medical devices / Malaysia / Sanctuary Health Sdn Bhd
Sanctuary Health Sdn Bhd: FDA-registered device maker in Chemor Perak, Malaysia, 1 510(k) clearance
Sanctuary Health Sdn Bhd is registered with the FDA (registration 3005497907) in Chemor Perak, Malaysia. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 28, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005497907
- Address
- No. 16 Persiaran Perindustrian Kanthan 1 Kawasan Perindustrian Kanthan, Chemor Perak, Malaysia, 31200
- Owner or operator
- Sanctuary Health Sdn Bhd (9080281)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 7, 2005
- Registered through
- 2027
- Brand names listed
- Dental Dam Premium Kit, Sanctuary ComfiTract Latex- Free Cheek Retractor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Std, Oral Sex | MSC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Components, Exercise | IOD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dental Prophylaxis Kit | NYC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Frame, Rubber Dam | EJE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 28, 2022 | K212037 | SancDam Latex Oral Dam | MSC | Substantially Equivalent | Sanctuary Health Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dental Prophylaxis Kit
- All makers of Exerciser, Non-Measuring
- All makers of Dam, Rubber
- All makers of Components, Exercise
- All makers of Retractor, All Types
- All makers of Frame, Rubber Dam
Updated March 28, 2022. 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.