HomeGermanyHeraeus Medical GmbH

Heraeus Medical GmbH

Germany · Wehrheim
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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
28listed device types
Class I 6Class II 18Class III 4
plus 81 registration records and 18 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 1Class III 1
17 including historic records
TWTaiwanTFDA
7valid device licences
Class I 2Class II 5
SGSingaporeHSA SMDR
8device registrations
CLASS B 2CLASS C 1D WITH MEDICINAL PRODUCT 5
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
15active ARTG entries
Class I 2Class III 9IIa 2IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
3active registrations
Class 2b 1Class 3 2
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 States81 registration records, 18 510(k), 0 PMA, 16 excluded
Brazil2 confirmed, 0 excluded
Canada2 confirmed, 2 excluded
Manufacturer names merged into this page: Heraeus Medical GmbH · Heraeus Medical Components Caribe, Inc. · Heraeus Medical Components, SRL · Heraeus Medical LLC · HERAEUS MEDICAL COMPONENTS, LLC · HERAEUS MEDICAL GMBH
Same-named companies — This database also contains companies with near-identical names: Heraeus Medical Components, SRL. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Wehrheim

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.

FDA 510(k) clearances by year

12003
12014
12015
12016
22017
12018
42019
12020
12021
22022
12023
22024

FDA listed device types

showing 8 of 28
Filler, Bone Void, Calcium Compound 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Stimulator, Spinal-Cord, Implanted (Pain Relief) 1Bone Cement, Antibiotic 1Endoscopic Guidewire, Gastroenterology-Urology 1Catheter, Septostomy 1Stylet, Catheter 1Wire, Guide, Catheter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241674OSTEOPAL® V2024-12-05
USK234028COPAL® exchange G hip spacer; COPAL® G+V2024-02-15
USK222570COPAL knee moulds2023-02-04
BR80102511284SISTEMA DE MISTURA A VÁCUO PALAMIX COM ACÚMULO DE VÁCUOClass II
BR80689090156Fio Guia Híbrido SOLO PLUSClass II
CA105435APPROACH AUTHORITY WORKHORSE MICROWIRE GUIDEClass II
CA88319COPAL SPACEMClass III

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