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Zibo Blue Sail Plastic & Rubber Products Co., Ltd.

China · Chaoyang District; Beijing

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel — 6 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

pendingnot queried

USUnited StatesFDA openFDA

17listed device types

Class I 16Class II 1Class III 0

plus 24 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

36registered devices

Class I 36

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

SASaudi ArabiaSFDA

13registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States24 registration records, 11 510(k), 0 PMA, 2 excluded

Brazil36 confirmed, 0 excluded

Saudi Arabia13 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: BLUE SAIL (HONG KONG) TRADING LIMITED · SHANDONG BLUE SAIL INNOVATION CO LTD · Zibo Blue Sail Innovation Co., Ltd · ZIBO BLUE SAIL HEALTH TECHNOLOGY CO., LTD · ZIBO BLUE SAIL INNOVATION CO., LTD · BLUE SAIL MEDICAL CO., LTD

Same-named companies — This database also contains companies with near-identical names: Blue Sail Medical Co., Ltd., Shandong Blue Sail Health Technology Co., Ltd., Shandong Blue Sail Innovation Co., Ltd., SHANDONG BLUE SAIL PLASTIC & RUBBER CO. LTD. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22003

42010 · K102161

12011 · K103619

22017 · K171782

22022 · K221229

FDA listed device types

showing 8 of 17

Cap, Surgical 1Accessory, Surgical Apparel 1Latex Patient Examination Glove 1Gown, Examination 1Non-Surgical Gown 1Mask, Scavenging 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221229	Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves	2022-07-16
US	K220228	Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs	2022-03-18
US	K171782	Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs	2017-10-12
BR	82090610005	MÁSCARA TRIPLA TNT II	Class I
BR	81818100012	Luva Vinil Com Pó	Class I
BR	80841790005	LUVA DE LÁTEX PARA PROCEDIMENTOS NÃO CIRÚRGICOS SEM PÓ DERMASOFT	Class I
SA	ME0000008936SFDAA00001	YASHFEEN VINYL GLOVES	—
SA	ME0000008936SFDAA00002	Sanita serv-u	—
CA	77039	POWDERED VINYL EXAMINATION GLOVE	Class II

Zibo Blue Sail Plastic & Rubber Products Co., Ltd.

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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