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SHAOXING REBORN MEDICAL DEVICES CO., LTD

China · Shaoxing Zhejiang

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Israel — 4 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

14listed device types

Class I 12Class II 2Class III 0

plus 14 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 1Class II 18

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States14 registration records, 0 510(k), 0 PMA

Brazil19 confirmed, 2 excluded

Manufacturer names merged into this page: SHAOXING REBORN MEDICAL DEVICES CO.,LTD · SHAOXING REBORN MEDICAL DEVICES CO., LTD

FDA listed device types

showing 8 of 14

Anesthesia Breathing Circuit Kit (Adult & Pediatric) 1Mask, Gas, Anesthetic 1Mask, Oxygen, Low Concentration, Venturi 1Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Connector, Airway (Extension) 1Mask, Oxygen 1Bag, Reservoir 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80200260021	Filtro Respiratório Descartável	Class I
BR	80808489018	Sonda de Aspiração Sistema Fechado BeCare - 72 horas	Class II
BR	80808489019	Sonda de Aspiração Sistema Fechado BeCare - 24 horas	Class II

SHAOXING REBORN MEDICAL DEVICES CO., LTD

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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