LiNA Medical ApS

Switzerland · Glostrup

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

18listed device types

Class I 7Class II 11Class III 0

plus 51 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

16active device licences

Class II 16

28 including historic records

TWTaiwanTFDA

11valid device licences

Class I 3Class II 8

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

38active ARTG entries

Class I 5IIa 13IIb 8Class Is (sterile) 12

HKHong KongMDACS

5valid listings

Class II 3Class III 2

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

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 States51 registration records, 17 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Canada16 confirmed, 0 excluded

Manufacturer names merged into this page: LiNA Medical AG · LiNA Medical Polska sp. z o.o · LiNA Medical ApS · LINA MEDICAL APS · LINA MEDICAL AG

FDA 510(k) clearances by year

12003

12006

12007

12011

22013

42014

22018

12019

12020

12022

12023

12024

FDA listed device types

showing 8 of 18

Forceps, Biopsy, Non-Electric 1Fluid Drainage Tray 1Forceps 1Hook, Surgical, General & Plastic Surgery 1Hysteroscope Accessories 1Retractor 1Accessories, Catheter 1Electrosurgical, Cutting & Coagulation & Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240227	LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)	2024-08-22
US	K223932	SafeAir combi (SFR-combi-US)	2023-04-26
US	K221085	LiNA OperaScope Needle	2022-09-02
BR	80533429014	MORCELADOR LAPAROSCÓPICO LINA XCISE	Class II
BR	80693240006	LiNa EndoBag	Class II
BR	80693240002	LiNA MAX FLOW	Class II
CA	29364	MENIETT PULSE GENERATOR	Class II
CA	66392	LINA EASY-BAG SPECIMEN RETRIEVAL SYSTEM	Class II
CA	66438	LINA-BAG TISSUE RETRIEVAL SYSTEM	Class II