HomeGermanyLRE Medical GmbH

LRE Medical GmbH

Germany · Nördlingen · www.lre.de
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 2 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
11listed device types
Class I 2Class II 9Class III 0
plus 6 registration records and 0 510(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
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
IVD import 2
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 Union795 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States6 registration records, 0 510(k), 0 PMA
United Kingdom0 confirmed, 1 excluded
Manufacturer names merged into this page: LRE MEDICAL GMBH

Company information

Country
Germany
Website
www.lre.de
Product categories
Manufacturing, Lifecycle & Obsolescence ManagementCDMO (Contract Development and Manufacturing Organization)General Product Development, Development & Design Transfer

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

LEI
967600387UCBMXW5AY56
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
1961-01-24
Registration authority
Commercial Register, no. HRB 5316
Registry record updated
2025-10-28

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

FDA listed device types

showing 8 of 11
Myoglobin, Antigen, Antiserum, Control 1Glucose Oxidase, Glucose 1Real Time Nucleic Acid Amplification System 1Immunoassay Method, Troponin Subunit 1Instrumentation For Clinical Multiplex Test Systems 1System, Test, Blood Glucose, Over The Counter 1Injector, Contrast Medium, Automatic 1System, Test, Breath Nitric Oxide 1

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