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Unimicro Medical Systems Co., Ltd.

China · Shenzhen Guangdong · www.unimicromed.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000014590

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia, Israel, Russia — 9 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

185UDI-DI device records

Class IIa 179Class IIb 6

USUnited StatesFDA openFDA

6listed device types

Class I 2Class II 4Class III 0

plus 7 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class IIa 8Class IIb 2

BRBrazilANVISA

22registered devices

Class I 2Class II 20

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

13 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

IIa 7IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union185 raw hits, 0 excluded, 185 confirmed

United States7 registration records, 5 510(k), 0 PMA

United Kingdom10 confirmed, 0 excluded

Brazil22 confirmed, 0 excluded

Manufacturer names merged into this page: UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. · UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD · UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO. LTD · UNIMICRO MEDICAL SYSTEMS CO. LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000014590
EU authorised representative: Wellkang Ltd
UK responsible person: WELLKANG UKRP LTD

FDA 510(k) clearances by year

22014 · K141593

32015 · K141594

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Laparoscope, General & Plastic Surgery 1Insufflator, Laparoscopic 1Pneumoperitoneum Needle 1Tubing/Tubing With Filter, Insufflation, Laparoscopic 1Tube, Smoke Removal, Endoscopic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06955797764397	Pediatric Trocar	Class IIa
EU	06955797764380	Pediatric Trocar	Class IIa
EU	06955797764373	Pediatric Trocar	Class IIa
EU	06955797763406	Barb Thread Cannula	Class IIa
UK	61875	Single Use Sterile electrical lap hook	Class IIb
UK	42412	Single Use Sterile Surgical Trocar with Cannula	Class IIa
UK	12750	Single Use Sterile Veress Needle	Class IIa
US	K141594	Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar	2015-08-10
US	K150068	Unimicro Veress Needle	2015-07-31
US	K142208	Monopolar Laparascopic Accessories	2015-04-13
BR	80984199013	KIT CÂNULA TROCARTE BLADELESS DS	Class II
BR	80984199014	Kit Cânula Trocarte KF	Class II
BR	80984199015	CÂNULA TROCARTE PEDIÁTRICA	Class II

Unimicro Medical Systems 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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