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Guard Medical, Inc.

USA · New York

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 10Class II 0Class III 0

plus 10 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 11

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

SASaudi ArabiaSFDA

1registered 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.

United States10 registration records, 7 510(k), 0 PMA, 15 excluded

Brazil11 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: XIANNING FULL GUARD MEDICAL PRODUCTS CO.,LTD · XIANNING FULL GUARD MEDICAL PRODUCTS CO., LTD. · Xianning Full Guard Medical Products Co., Ltd.

Same-named companies — This database also contains companies with near-identical names: XIANNING FULL GUARD MEDICAL PRODUCTS CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12020 · K200305

12021 · K211130

12022 · K212971

22024 · K241522

22025 · K251156

FDA listed device types

showing 8 of 10

Cap, Surgical 1Dress, Surgical 1Accessory, Surgical Apparel 1Shoes, Operating-Room 1Non-Surgical Gown 1Helmet, Surgical 1Suit, Surgical 1Cover, Shoe, Operating-Room 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251156	NPseal	2025-05-15
US	K250708	NPseal	2025-04-08
US	K241522	NPseal (20 and 25)	2024-08-15
BR	81003690001	Kit Cirúrgico Descartável	Class I
BR	81003690002	CAMPO CIRURGICO HOSPITALAR ESTERIL	Class I
BR	81003690003	Aventais Cirúrgicos Estéril	Class I
SA	ME0000003489SFDAA00002	Vision	—

Guard Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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