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Sino Protection(Hefei) Medical Products Co., Ltd

China · Hefei Anhui · www.sino-protection.com

✓ 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

pendingnot queried

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

19listed device types

Class I 9Class II 10Class III 0

plus 34 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class I 2

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

7active ARTG entries

Class I 3Class Is (sterile) 4

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 Union530 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States34 registration records, 1 510(k), 0 PMA, 13 excluded

United Kingdom2 confirmed, 9 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia0 confirmed, 1 excluded

Manufacturer names merged into this page: Sino Protection (Hefei) Medical Products Co. ltd. · SINO PROTECTION(YANGON)NON-WOVEN COMPANY LIMITED · SINO CANADA HEALTH ENGINEERING RESEARCH INSTITUTE (HEFEI) LTD. (SCHERI) · Sino Protection Holding Co Limited Egypt Branch Ismailia Free Zone

Regulatory identity

UK responsible person: Etheria Medical Ltd

FDA 510(k) clearances by year

12023 · K223875

FDA listed device types

showing 8 of 19

Cap, Surgical 1Accessory, Surgical Apparel 1Gown, Examination 1Non-Surgical Gown 1Board, Arm (With Cover), Sterile 1Skin Prep Tray 1Ear, Nose, And Throat Surgical Tray 1Fiber, Medical, Absorbent 1

Market	Identifier	Name	Class / date
UK	47783	Surgical Drape	Class I
UK	35091	Surgical Gown	Class I
US	K223875	MOBINEURO Alita Intraoperative MRI System	2023-03-20

Sino Protection(Hefei) Medical Products Co., Ltd

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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