Data / Medical devices / China / Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd: FDA-registered device maker in Shenzhen City Guangdong, China, 7 510(k) clearances
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd is registered with the FDA (registration 3007539307) in Shenzhen City Guangdong, China. It lists 10 device types. The FDA files 7 510(k) clearances 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
- 3007539307
- Address
- 903, Tower B, OCT Central One, Mintang Road, Longhua District, Shenzhen City Guangdong, China, 518131
- Owner or operator
- Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. (10038881)
- Roles
- Exporter to the US, Specification developer
- First device listed
- November 20, 2011
- Registered through
- 2026
- Brand names listed
- Equipment Cover Product, Ice Wrap, Procedure Mask, Protective Clothing, Safe Secure Sterilization Pouches and Rolls, Specimen Transport Bag; Biohazard Bag, Sterilization Pouch, Sterilization Pouches and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Exporter to the US | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Sling, Arm, Overhead Supported | ILE | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Exporter to the US, Specification developer | 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 |
| July 22, 2016 | K160908 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | FRG | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 26, 2014 | K123162 | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | FRG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| February 7, 2012 | K112591 | SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS | FRG | Substantially Equivalent | Safe Secure Packaging Co., Ltd. | accessdata.fda.gov |
| September 22, 2003 | K032065 | MEDLINE BAND BAGS AND EQUIPMENT COVERS | MMP | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Bag, Ice
- All makers of Non-Surgical Gown
- All makers of Accessory, Surgical Apparel
- All makers of Lift, Patient, Non-Ac-Powered
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.