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UNISIS CORP.

✓ Record-verifiedregistrations found in 7 marketsEU SRN JP-MF-000026339

This company has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Australia, Israel — 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

13UDI-DI device records

Class III 13

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 23 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class III 1

BRBrazilANVISA

3registered devices

Class I 2Class II 1

8 including historic records

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

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union13 raw hits, 0 excluded, 13 confirmed

United States23 registration records, 2 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Brazil3 confirmed, 1 excluded

Manufacturer names merged into this page: UNISIS CORP · UNISIS CORP. · UNISIS, CORP . · UNISIS CORPORATION · UNISIS, CORP.

Regulatory identity

EU manufacturer SRN: JP-MF-000026339
EU authorised representative: Advena Limited
UK responsible person: Advena Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	14589402443675	UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE	Class III
EU	14589402443644	UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE	Class III
EU	14589402443637	UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE	Class III
EU	14589402443521	UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE	Class III
UK	35212	Neurafit Quincke Needle	Class III
US	K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle	2015-01-14
US	K141126	UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE	2014-10-31
BR	10150470418	Seringa Plástica Epidural Para Perda de Resistência Uniever Unisis	Class II
BR	10150470358	Agulha para Biópsia Chiba Descartável Uniever	Class I
BR	10150470265	SERINGA PLASTICA EPIDURAL PARA PERDA DE RESISTENCIA UNISIS	Class I

UNISIS CORP.

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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