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Meridian Medical d.o.o.

Slovenia · Ljubljana-Sentvid

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia, Israel — 6 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

pendingnot queried

USUnited StatesFDA openFDA

13listed device types

Class I 5Class II 8Class III 0

plus 15 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

12 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

4active ARTG entries

IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

United States15 registration records, 15 510(k), 0 PMA, 13 excluded

Brazil0 confirmed, 7 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: MERIDIAN MEDICAL LIMITED · Meridian Medical d.o.o. · MERIDIAN MEDICAL SYSTEMS INC.

Same-named companies — This database also contains companies with near-identical names: MERIDIAN MEDICAL LIMITED, Meridian Medical Systems, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21994

11997

12000

22001

12002

12003

12006

12011

22012

12014

12015

12016

FDA listed device types

showing 8 of 13

Retractor, Self-Retaining 1Kit, Surgical Instrument, Disposable 1Probe And Director, Gastro-Urology 1Accessories, Catheter 1Operating Room Accessories Table Tray 1Device, Cystometric, Hydraulic 1Catheter, Conduction, Anesthetic 1Prosthesis, Hip, Femoral Component, Cemented, Metal 1

Market	Identifier	Name	Class / date
US	K162687	Paragon 2	2016-10-21
US	K143232	Universal Digital Interface 2W, UDI 2W	2015-01-30
US	K140251	UNIVERSAL DIGITAL INTERFACE 2, UDI 2	2014-10-22

Meridian Medical d.o.o.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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