FDA Registration
Active
🇨🇳 China
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd
Reg #: 3007539307
·
FEI: 3007539307
·
Expires 2026
Products
10
Proprietary Names
10
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd
- Registration Number
- 3007539307
- FEI Number
- 3007539307
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 903, Tower B, OCT Central One, Mintang Road, Longhua District
- City
- Shenzhen City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K160908
Owner / Operator
- Firm Name
- Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd.
- Operator Number
- 10038881
- Address
- 903, Tower B, OCT Central One, Mintang Road, Longhua District
- City
- Shenzhen city
- State
- Guangdong
- Postal Code
- 518131
- Country
- CN
- Correspondent
- Patty Chen
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2016-08-15 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2016-11-16 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2024-12-16 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-13 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2016-08-15 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-13 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2016-01-31 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2019-04-10 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-10-16 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2011-11-20 |
Proprietary Names
Vis-U-All Low Temperature Sterilization Pouch/Tubing
Safe Secure Sterilization Pouches and Rolls
Procedure Mask
Sterilization Pouch
Sterilization Pouches / Sterilization Rolls
Protective Clothing
Ice Wrap
Equipment Cover Product
Sterilization Pouches
Specimen Transport Bag; Biohazard Bag
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility