Home›Germany›HEIDELBERG ENGINEERING GMBH

HEIDELBERG ENGINEERING GMBH

Germany · Heidelberg

✓ 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

5listed device types

Class I 0Class II 5Class III 0

plus 10 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

5active device licences

Class II 5

9 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

12active ARTG entries

Class I 1IIa 10IIb 1

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 States10 registration records, 26 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: HEIDELBERG ENGINEERING GMBH

FDA 510(k) clearances by year

11991

31994

11997

12004

22006

12010

12011

12012

12016

12017

32018

12019

12020

12021

22023

32024

12025

12026

FDA listed device types

System, Image Processing, Radiological 1System, Image Management, Ophthalmic 1Device, Analysis, Anterior Segment 1Ophthalmoscope, Laser, Scanning 1Tomography, Optical Coherence 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253837	SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module	2026-05-07
US	K250868	SPECTRALIS HRA+OCT and variants	2025-05-12
US	K240924	Anterion	2024-12-13
BR	81346509004	Sistema de tomografia de coerência optica para diagnóstico do segmento	Class I
BR	81346509005	Sistema de Tomografia de Coerência Optica para Segmento Anterior.	Class II
BR	80170280052	TOMÓGRAFO DE RETINA HEIDELBERG - HRT3	Class II
CA	60912	HEIDELBERG RETINA TOMOGRAPH II (HRT II)	Class II
CA	63020	HEIDELBERG RETINA ANGIOGRAPH 2 (HRA 2) COMBI SYSTEM	Class II
CA	66512	HEIDELBERG RETINA TOMOGRAPH II ROSTOCK CORNEA MODULE (RCM)	Class II