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Leonhard Lang GmbH

Austria · Innsbruck · www.leonhardlang.at

✓ Record-verifiedregistrations found in 11 marketsEU SRN AT-MF-000000426

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥216, the first 300 verified individually. 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

≥216UDI-DI device records

Class I 215Class IIb 1

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

12listed device types

Class I 1Class II 10Class III 1

plus 22 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 6Class IIb 2

BRBrazilANVISA

2registered devices

Class I 2

5 including historic records

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 12IIb 2

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 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.

European Union992 raw hits, 84 excluded, 216 confirmed. Large result set — only the first 300 verified

United States22 registration records, 19 510(k), 0 PMA

United Kingdom8 confirmed, 8 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Manufacturer names merged into this page: LEONHARD LANG GMBH · LEONHARD LANG GmbH

Business registration

LEI: 529900WTUW4D65YIOB16
Registration status: Active
Legal form: Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated: 1994-01-25
Registered address: Archenweg 56, Innsbruck, 6020
Registration authority: Commercial Register, no. 77514t
Registry record updated: 2026-02-23

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

FDA 510(k) clearances by year

11999

12002

52003

22004

12006

22007

22008

12009

12011

32014

FDA listed device types

showing 8 of 12

Automated External Defibrillators (Non-Wearable) 1System, Network And Communication, Physiological Monitors 1Electrosurgical, Cutting & Coagulation & Accessories 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Monitor, Breathing Frequency 1Electrode, Electrocardiograph, Multi-Function 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	10854661006447	S & W	Class I
EU	10854661006430	S & W	Class I
EU	19005531001234	ASMUTH	Class I
EU	19005531000220	Skintact	Class I
UK	47487	Skintact	Class I
UK	35035	GEHC ECG Electrodes	Class I
UK	58494	Megadyne, Neutral Electrodes	Class IIb
US	K142803	Skintact, various other tradenames	2014-12-02
US	K140500	SKINTACT	2014-07-29
US	K140340	SKINTACT	2014-05-21
BR	10150470109	ELETRODO ECG LEONHARD LANG	Class I
BR	10150470423	Eletrodo E.C.G Skintact Leonhard Lang	Class I
SA	ME0000005942SFDAA00007	BabyMac Infant/Pediatric	—
SA	ME0000005942SFDAA00008	Silver Mactrode Plus	—