Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 10 device types, 1 product catalogued, 3 clearances.
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Bag, Ice, Non-Surgical Gown and 8 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007539307 |
| FEI number | 3007539307 |
| DUNS | 527295522 |
| Establishment type | Specification developer, Manufacturer, Exporter |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 903, Tower B, OCT Central One, Mintang Road, Longhua District |
| Postal code | 518131 |
| Country | China |
Group
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. is one of 2 plants registered under Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd..
| Plant | City | Device types |
|---|---|---|
| Dongguan SafeSecure Plastics Co., Ltd. | Dongguan | 6 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Procedure Mask | 2020 | 439 |
| Bag, Ice | Class 1 | Ice Wrap | 2016 | 86 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Specimen Transport Bag; Biohazard Bag | 2011 | 51 |
| Cover, Barrier, Protective | Class 2 | Equipment Cover Product | 2019 | 15 |
| Drape, Surgical, Exempt | Class 2 | 2017 | 107 | |
| Indicator, Physical/Chemical Sterilization Process | Class 2 | Safe Secure Sterilization Pouches and Rolls | 2024 | 19 |
| Lift, Patient, Non-Ac-Powered | Class 1 | 2016 | 71 | |
| Non-Surgical Gown | Class 1 | Protective Clothing | 2020 | 318 |
| Sling, Arm, Overhead Supported | Class 1 | 2016 | 31 | |
| Wrap, Sterilization | Class 2 | Vis-U-All Low Temperature Sterilization Pouch/Tubing, Sterilization Pouches / Sterilization Rolls, Safe Secure Sterilization Pouches and Rolls, Sterilization Pouch, Sterilization Pouches | 2012 | 38 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| SafeSecure | FXX | 1 |
Clearances
3 clearances name Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. as applicant. 6 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251991 | 2025-12-23 | JOJ | Traditional | This company |
| K242839 | 2024-10-16 | FRG | Traditional | This company |
| K213358 | 2022-03-04 | FXX | Traditional | This company |
| K180139 | 2019-01-03 | FRG | Traditional | Safe Secure Packing Co., Ltd. |
| K153540 | 2016-08-04 | FRG | Traditional | Safe Secure Packaging Co., Ltd. |
| K160908 | 2016-07-22 | FRG | Traditional | Steris Corporation |
| K123162 | 2014-02-26 | FRG | Traditional | U&U Medical Technology Co., Ltd. |
| K112591 | 2012-02-07 | FRG | Traditional | Safe Secure Packaging Co., Ltd. |
| K032065 | 2003-09-22 | MMP | Traditional | Medline Industries, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Main products | Medical infection control consumables, Disposable respirators, Face masks |
| Certifications | ISO 11135, FDA registration |
| Export markets | Global (60% US hospital market coverage) |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.