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Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000010512

This company has registrations in European Union, United States, United Kingdom, Australia, Israel — 5 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

64UDI-DI device records

Class I 32Class IIa 17Class IIb 15

USUnited StatesFDA openFDA

14listed device types

Class I 6Class II 8Class III 0

plus 13 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

45registered device records

Class I 14Class IIa 13Class IIb 18

BRBrazilANVISA

0registered devices

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

8active ARTG entries

Class I 5IIa 1Class Is (sterile) 2

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 Union64 raw hits, 0 excluded, 64 confirmed

United States13 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom45 confirmed, 0 excluded

Manufacturer names merged into this page: CHANGZHOU INTL. TRADE & ENTERPRISES COOPERATIVE CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000010512
EU authorised representative: RIOMAVIX SOCIEDAD LIMITADA
UK responsible person: Pennamed Limited

FDA listed device types

showing 8 of 14

Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1Endoscopic Bite Block 1Instrument, Surgical, Disposable 1Stapler, Skin 1Adaptor, Bulbs, Miscellaneous, For Endoscope 1Trap, Sterile Specimen 1Bougie, Esophageal, And Gastrointestinal, Gastro-Urology 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06970057555492	Disposable Endoscopic Retrieval Bag	Class IIa
EU	06970057555478	Disposable Endoscopic Retrieval Bag	Class IIa
EU	06975238204367	Tubulure d’irrigation	Class I
EU	06975238204350	Clean Cap sans connexion à CO2	Class I
UK	43691	Bare-metal biliary stent	Class IIb
UK	37847	Bare-metal colonic stent	Class IIb
UK	32640	Bare-metal duodenal stent	Class IIb

Changzhou Intl. Trade & Enterprises Cooperative 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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