HomeGermanyHeraeus Medical GmbH Technology

Heraeus Medical GmbH Technology

Germany · Wehrheim
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
10listed device types
Class I 4Class II 6Class III 0
plus 46 registration records and 14 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
10 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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.

United States46 registration records, 14 510(k), 0 PMA, 21 excluded
Brazil1 confirmed, 1 excluded
Canada1 confirmed, 3 excluded
Manufacturer names merged into this page: Heraeus Medical GmbH · Heraeus Medical LLC · HERAEUS MEDICAL GMBH

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
12018
22019
12020
12021
22022
12023
22024

FDA listed device types

showing 8 of 10
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Bone Cement, Antibiotic 1Bone Cement 1Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented 1Prosthesis, Hip, Hemi-, Femoral, Metal 1Cement, Bone, Vertebroplasty 1Dispenser, Cement 1Template 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
CA88319COPAL SPACEMClass III

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