Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036679484

FEI Number

3036679484

Entity Name

SAFESECURE MEDICAL PACKAGING COMPANY LIMITED

City/State/Country

Hai Phong City, VN

Establishment Address

Dai Hoang 1 Village, Tan Dan Town, An Lao District, Hai Phong City 04520, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SAFESECURE MEDICAL INFECTION CONTROL PTE. (Owner Number: 10092731)

Owner / Operator Contact Address

8 KAKI BUKIT AVENUE 4, #08-32, PREMIER @ KAKI BUKIT, SINGAPORE, SG-04 415875, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242839

PMA Number

N/A

All Registered Proprietary Names

Sterilization Pouches / Sterilization Rolls Equipment Cover Ice Wrap UNASling Sterilization Pouches / Sterilization Rolls Specimen Transport Bag Biohazard Bag Sterilization Pouches / Sterilization Rolls

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-03-18
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-03-18
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2025-03-18
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2025-03-18
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-03-18
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2025-03-18
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-02-11
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-02-11

Official Correspondent

Parker Lee

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

SAFESECURE MEDICAL INFECTION CONTROL PTE.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038138452	SAFESECURE MEDICAL INFECTION CONTROL PTE.	SINGAPORE South East, SG

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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1054380	Halyard North Carolina, LLC	LINWOOD, NC, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036679484. Last updated year: 2026. Please use registration number 3036679484 when referencing this establishment in official correspondence.