XION GmbH

Germany · Berlin

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Australia — 4 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

6listed device types

Class I 2Class II 4Class III 0

plus 6 registration records and 1 510(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

21active device licences

Class II 21

32 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 5

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.

United States6 registration records, 1 510(k), 0 PMA

Canada21 confirmed, 0 excluded

Manufacturer names merged into this page: XION GmbH · XION GMBH

FDA 510(k) clearances by year

12007 · K070580

FDA listed device types

Hysteroscope (And Accessories) 1Nasopharyngoscope (Flexible Or Rigid) 1Cystoscope And Accessories, Flexible/Rigid 1Laparoscope, General & Plastic Surgery 1Otoscope 1Accessories, Arthroscopic 1

Market	Identifier	Name	Class / date
US	K070580	NASOPHARYNGOSCOPE, BRONCHOSCOPE	2007-06-13
CA	66970	RIGID ENDOSCOPES - LAPAROSCOPY	Class II
CA	66971	VIDEO LARYNGOSCOPES	Class II
CA	67160	ENT ENDOSCOPES	Class II

XION GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies