Data / Medical devices / Vietnam / Safesecure Medical Packaging Company Limited
Safesecure Medical Packaging Company Limited: FDA-registered device maker in Hai Phong City, Vietnam, 1 510(k) clearance
Safesecure Medical Packaging Company Limited is registered with the FDA (registration 3036679484) in Hai Phong City, Vietnam. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036679484
- Address
- Dai Hoang 1 Village Tan Dan Town, An Lao District, Hai Phong City, Vietnam, 04520
- Owner or operator
- SAFESECURE MEDICAL INFECTION CONTROL PTE. (10092731)
- Roles
- Contract manufacturer, Manufacturer
- 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 | Contract manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer | accessdata.fda.gov |
| Sling, Arm, Overhead Supported | ILE | 1 | Contract manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 16, 2024 | K242839 | Safe Secure Sterilization Pouches and Rolls | FRG | Substantially Equivalent | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Drape, Surgical, Exempt
- All makers of Sling, Arm, Overhead Supported
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Wrap, Sterilization
- All makers of Bag, Ice
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.