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Infection Control Forum

Germany · Düsseldorf

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, United Kingdom, Australia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

10listed device types

Class I 6Class II 4Class III 0

plus 21 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 3

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union468 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States21 registration records, 8 510(k), 0 PMA, 1 excluded

United Kingdom3 confirmed, 3 excluded

Manufacturer names merged into this page: Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd · SAFESECURE MEDICAL INFECTION CONTROL PTE.

Same-named companies — This database also contains companies with near-identical names: Infection Control Guardian (Shandong) Medical Technology Co.Ltd. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

UK responsible person: SUNGO Certification Company Limited

FDA 510(k) clearances by year

31990 · K900643

11994 · K935779

12004 · K040956

12022 · K213358

12024 · K242839

12025 · K251991

FDA listed device types

showing 8 of 10

Wrap, Sterilization 1Cover, Barrier, Protective 1Indicator, Physical/Chemical Sterilization Process 1Drape, Surgical, Exempt 1Sling, Arm, Overhead Supported 1Accessory, Surgical Apparel 1Bag, Ice 1Non-Surgical Gown 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	57958	Lip Shield	Class I
UK	63108	Wound Care	Class I
UK	13735	Sterilization pouch and roll	Class I
US	K251991	SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)	2025-12-23
US	K242839	Safe Secure Sterilization Pouches and Rolls	2024-10-16
US	K213358	Surgical Mask	2022-03-04

Infection Control Forum

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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