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Excellent Medical Technology Group Co., Ltd.

China · Suzhou · www.excellentmedical.cn

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000022462

This company has registrations in European Union, United States, Brazil, Israel — 4 overseas markets. EU UDI-DI records ≥61, the first 300 verified individually. 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

≥61UDI-DI device records

Class I 61

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

45listed device types

Class I 35Class II 7Class III 0unclassified 3

plus 67 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class I 1

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

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

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 Union534 raw hits, 239 excluded, 61 confirmed. Large result set — only the first 300 verified

United States67 registration records, 1 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 3 excluded

Manufacturer names merged into this page: EXCELLENT_MEDICAL_TECHNOLOGY(THAILAND)_CO.,_LTD. · EXCELLENT MEDICAL TECHNOLOGY CO.,LTD · ZHEJIANG EXCELLENT UNITED MEDICAL TECHNOLOGY CO.,LTD · EXCELLENT MEDICAL TECHNOLOGY (THAILAND) CO., LTD. · EXCELLENT MEDICAL TECHNOLOGY GROUP CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000022462
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)

FDA 510(k) clearances by year

12022 · K220665

FDA listed device types

showing 8 of 45

Urinary Drainage Collection Kit, For Indwelling Catheter 1Gown, Surgical 1Collector, Urine, (And Accessories) For Indwelling Catheter 1Drape, Surgical, Exempt 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Tubing, Noninvasive 1General Surgery Tray 1Pad, Eye 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06972823187708	Binocular drape 40x50 cm 081369	Class I
EU	06972823183731	SURGICAL DRAPE,150-200 B-002 150-200 6501	Class I
EU	06972823183830	SURGICAL DRAPE,150-240 B-002 150-240 6501	Class I
EU	06972823183793	SURGICAL DRAPE,75-90 B-002 75-90 6324	Class I
US	K220665	Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile	2022-06-03
BR	81976230002	CURADH - NEXAGUARD BVB	Class I

Excellent Medical Technology Group Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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