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Optima International AB

Sweden · Uppsala · www.optima.se

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 3 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

2 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union3,940 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 3 510(k), 0 PMA, 3 excluded

United Kingdom0 confirmed, 10 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION

Business registration

Legal name: Optima International Aktiebolag
LEI: 254900YQIKK1AEWH1B94
Registration status: Active
Legal form: Aktiebolag (AB)
Incorporated: 1994-03-02
Registered address: Gunstagatan 16, Uppsala, 753 24
Registration authority: Companies Register, no. 556483-9610
Registry record updated: 2025-12-12

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Market	Identifier	Name	Class / date
US	K192629	Spinalytics	2019-12-21
US	K130666	KHAN KINETIC TREATMENT (KKT-M2)	2014-01-23
US	K060043	KHAN KINETIC TREATMENT DEVICE (KKT-M1)	2006-03-23

Optima International AB

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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