HomeChinaInfection Control Guardian (Shandong) Medical Technology Co.Ltd

Infection Control Guardian (Shandong) Medical Technology Co.Ltd

China · 德州 · www.sdgkws.com
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 91371402MA3QN6UGXF

This company holds 5 NMPA certificates in China and has registrations in United States — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class I 5
as of 2026-09-04
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
0registered device records
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 Union555 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
China5 certificates (Class III 0 / II 0 / I 5), as of 2026-09-04
United Kingdom0 confirmed, 2 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 Forum. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

Unified social credit code
91371402MA3QN6UGXF
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
52
Annual revenue
RMB 50–100M
Website
www.sdgkws.com
Product categories
医疗器械消毒灭菌器械消毒感控输血及体外循环口腔手术室及急救

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2019-09-27
Registered capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-06-02
Recognitions
National High-Tech EnterpriseTechnology-based SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

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)

MarketIdentifierNameClass / date
CN鲁德械备20230077清洗液Class I
CN鲁德械备20230006号手动病床Class I
CN鲁德械备20220131号医用隔离面罩Class I
CN鲁德械备20210084号内镜清洗工作站Class I
USK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)2025-12-23
USK242839Safe Secure Sterilization Pouches and Rolls2024-10-16
USK213358Surgical Mask2022-03-04

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