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Ucomfor Scientific Co., Ltd.

China · Zhangjiagang Jiangsu · www.ucomfor.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000016602

This company has registrations in European Union, United States, United Kingdom, Brazil, 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

48UDI-DI device records

Class I 48

USUnited StatesFDA openFDA

13listed device types

Class I 5Class II 8Class III 0

plus 15 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

13registered device records

Class I 11Class IIa 2

BRBrazilANVISA

11registered devices

Class I 7Class II 4

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

11active ARTG entries

Class I 2IIa 2Class Im (measuring) 1Class Is (sterile) 6

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.

European Union48 raw hits, 0 excluded, 48 confirmed

United States15 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom13 confirmed, 0 excluded

Brazil11 confirmed, 0 excluded

Manufacturer names merged into this page: UCOMFOR SCIENTIFIC CO.,LTD · UCOMFOR SCIENTIFIC CO. LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000016602
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Fresenius Kabi Limited

FDA listed device types

showing 8 of 13

Catheter And Tip, Suction 1Tube, Aspirating, Flexible, Connecting 1Collector, Urine, (And Accessories) For Indwelling Catheter 1Respirator, Surgical 1Mask, Surgical 1Device, Urine Flow Rate Measuring, Non-Electrical, Disposable 1Speculum, Vaginal, Nonmetal 1Gastrointestinal Tubes With Enteral Specific Connectors 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06972261820786	BEXEN MEDICAL ENFIT STRAW	Class I
EU	06972261820793	BEXEN MEDICAL ENFIT STRAW	Class I
EU	06972261820809	BEXEN MEDICAL ENFIT STRAW	Class I
EU	06972261820816	BEXEN MEDICAL ENFIT STRAW	Class I
UK	11675	Hydorbag	Class I
UK	11301	1000ml PVC drainage bag with 50cm inlet tubing and hooks	Class I
UK	64461	1000mL EVA Feeding Bag Set	Class I
BR	82926680001	Extensor para Nutrição Enteral	Class I
BR	82926689001	Bulbo de Silicone	Class II
BR	82926689002	Sonda Nasogástrica	Class II

Ucomfor Scientific Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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