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Surgicon (Pvt.) Ltd.

Pakistan · Sialkot · www.surgicon.com.pk

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

103listed device types

Class I 103Class II 0Class III 0

plus 105 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

2registered devices

Class I 1Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

17registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union1,642 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States105 registration records, 2 510(k), 0 PMA

United Kingdom1 confirmed, 1 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia17 confirmed, 0 excluded

Manufacturer names merged into this page: SURGICON PVT LTD · SURGICON AG · SURGICON, INC. · SURGICON (PVT) LTD · SURGICON (PVT) LTD.

Regulatory identity

UK responsible person: Advena Ltd

FDA 510(k) clearances by year

12002 · K021747

12003 · K033359

FDA listed device types

showing 8 of 103

Container, Specimen, Sterile 1Chisel, Surgical, Manual 1Needle, Aspiration And Injection, Disposable 1Gag, Mouth 1Spud, Ophthalmic 1Fork, Tuning 1Sound, Uterine 1Contractor, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	46741	Ophthalmic Microsurgical Knives	Class IIa
US	K033359	DEGALL II GALLBLADDER EXTRACTOR	2003-12-19
US	K021747	DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR	2002-08-15
BR	81044960023	Instrumentais para Coluna Vertebral e Neurocirurgia - Surgicon	Class I
BR	80443079019	Instrumentos Cirúrgicos Classe II-RVI SURGICON AG	Class II
SA	ME0000001599SFDAA00021	Thyroidectomy Set	—
SA	ME0000001599SFDAA00027	GYNECOLOGY SET	—

Surgicon (Pvt.) 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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