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Andreas Hettich GmbH

Germany · Tuttlingen · www.hettichlab.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN DE-MF-000010680

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 11 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

112UDI-DI device records

Class IIa 25IVD A 83IVD general 4

USUnited StatesFDA openFDA

10listed device types

Class I 6Class II 4Class III 0

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

IVD A 1

BRBrazilANVISA

7registered devices

Class I 3Class II 4

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

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

IVD import 4

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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 Union116 raw hits, 4 excluded, 112 confirmed

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

United Kingdom1 confirmed, 1 excluded

Brazil7 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: ANDREAS HETTICH GMBH · ANDREAS HETTICH GMBH & CO. KG

Regulatory identity

EU manufacturer SRN: DE-MF-000010680
UK responsible person: MEDAGENT INTERNATIONAL UK LIMITED

Business registration

Legal name: Dr. Andreas Hettich Invest GmbH & Co. KG
LEI: 3912004XTD5UOUSH9918
Registration status: Inactive
Legal form: Kommanditgesellschaft (KG)
Incorporated: 2007-12-10
Registration authority: Commercial Register, no. HRA 200904
Registry record updated: 2024-12-10

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 10

Hematocrit, Tube, Rack, Sealer, Holder 1Platelet And Plasma Separator For Bone Graft Handling 1Centrifuge, Hematocrit 1Device, Hematocrit Measuring 1Centrifuge, Blood-Bank For In Vitro Diagnostic Use 1Cytocentrifuge 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04050674098243	MIKRO 2.0 R(IVD), 100-240V/50-60Hz	IVD A
EU	04050674098236	MIKRO 2.0 (IVD), 100-240V/50-60Hz	IVD A
EU	04050674082716	ROTANTA 460 RF, 100-127V 60Hz 100V 50Hz	Class IIa
EU	04050674067539	ROTANTA 460 RF, 200-240V 50Hz	Class IIa
UK	36465	ROTANTA 460 Robotic, 230-240V 50-60Hz	IVD A
BR	80159769003	Centrifuga para banco de sangue e laboratório	Class II
BR	80159769001	CENTRIFUGA HETTICH	Class II
BR	80159769002	CENTRIFUGA REFRIGERADA HETTICH	Class I
CA	87617	TACSI (TERUMO AUTOMATED CENTRIFUGE & SEPARATOR INTEGRATION)	Class II