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ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.

China · Shaoxing Zhejiang

✓ Record-verifiedregistrations found in 6 markets

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

21listed device types

Class I 18Class II 3Class III 0

plus 22 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 1Class II 4

6 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 1Class 2a 3

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 States22 registration records, 2 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. · ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD · Zhejiang Haisheng Medical Device Co., Ltd

FDA 510(k) clearances by year

12015 · K151498

12016 · K152472

FDA listed device types

showing 8 of 21

Anesthesia Breathing Circuit Kit (Adult & Pediatric) 1Mask, Gas, Anesthetic 1Syringe, Irrigating (Non Dental) 1Laryngoscope, Rigid 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Adaptor, Holder, Syringe 1Staple, Removable (Skin) 1Connector, Airway (Extension) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152472	Disposable Pressure Transducer	2016-10-31
US	K151498	Breathing circuit bacterial/viral filter	2015-12-18
BR	81194869012	Circuito Expansível Descartável Promédica	Class II
BR	10150479162	Trocador de Calor e Umidade para Traqueostomia Hisern	Class II
BR	10150479096	Filtro HMEF Hisern	Class II
SA	ME0000006703SFDAA00001	Medical Soda Lime	—

ZHEJIANG HAISHENG MEDICAL DEVICE 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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