Data / Medical devices / Singapore / Safesecure Medical Infection Control Pte.
Safesecure Medical Infection Control Pte.: FDA-registered device maker in SINGAPORE South East, Singapore, 3 510(k) clearances
Safesecure Medical Infection Control Pte. is registered with the FDA (registration 3038138452) in SINGAPORE South East, Singapore. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 16, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3038138452
- Address
- 8 Kaki Bukit Avenue 4 #08-32, Premier @ Kaki Bukit, SINGAPORE South East, Singapore, 415875
- Owner or operator
- SAFESECURE MEDICAL INFECTION CONTROL PTE. (10092731)
- Roles
- Exporter to the US
- First device listed
- February 11, 2025
- Registered through
- 2026
- Brand names listed
- Biohazard Bag, Equipment Cover, Ice Wrap, Specimen Transport Bag, Sterilization Pouches / Sterilization Rolls, UNASling
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Ice | KYR | 1 | Exporter to the US | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Exporter to the US | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Exporter to the US | accessdata.fda.gov |
| Sling, Arm, Overhead Supported | ILE | 1 | Exporter to the US | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| October 16, 2024 | K242839 | Safe Secure Sterilization Pouches and Rolls | FRG | Substantially Equivalent | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | accessdata.fda.gov |
| January 3, 2019 | K180139 | Safe Secure Sterilization Pouches and Rolls | FRG | Substantially Equivalent | Safe Secure Packing Co., Ltd. | accessdata.fda.gov |
| August 4, 2016 | K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | FRG | Substantially Equivalent | Safe Secure Packaging Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Wrap, Sterilization
- All makers of Bag, Ice
- All makers of Drape, Surgical, Exempt
- All makers of Sling, Arm, Overhead Supported
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated October 16, 2024. 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.