HomeChinaZibo Blue Sail Innovation Co., Ltd

Zibo Blue Sail Innovation Co., Ltd

China · Zibo
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 7 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 9 510(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
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 6
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, 9 510(k), 0 PMA, 3 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.

Company information

Country
China
City
Zibo

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.

FDA 510(k) clearances by year

22003 · K032781
22010 · 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)

MarketIdentifierNameClass / date
USK221229Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves2022-07-16
USK220228Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs2022-03-18
USK171782Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs2017-10-12
BR82090610005MÁSCARA TRIPLA TNT IIClass I
BR81818100012Luva Vinil Com PóClass I
BR80841790005LUVA DE LÁTEX PARA PROCEDIMENTOS NÃO CIRÚRGICOS SEM PÓ DERMASOFTClass I
SAME0000008936SFDAA00001YASHFEEN VINYL GLOVES
SAME0000008936SFDAA00002Sanita serv-u
CA77039POWDERED VINYL EXAMINATION GLOVEClass II

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