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Helmut Zepf Medizintechnik GmbH

Germany · Seitingen-Oberflacht · www.zepf-dental.com

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 7 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

96listed device types

Class I 94Class II 2Class III 0

plus 96 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

38registered device records

Class I 35Class IIa 1Class IIb 2

BRBrazilANVISA

28registered devices

Class I 28

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

87registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States96 registration records, 0 510(k), 0 PMA

United Kingdom38 confirmed, 0 excluded

Brazil28 confirmed, 0 excluded

Saudi Arabia87 confirmed, 0 excluded

Manufacturer names merged into this page: HELMUT ZEPF MEDIZINTECHNIK GMBH · Helmut Zepf Medizintechik GmbH · Helmut Zepf Medizintechnik GmbH

Regulatory identity

UK responsible person: MEDAGENT INTERNATIONAL UK LIMITED

FDA listed device types

showing 8 of 96

Knife, Margin Finishing, Operative 1Band, Preformed, Orthodontic 1Syringe, Restorative And Impression Material 1Accessories, Implant, Dental, Endosseous 1Drill, Dental, Intraoral 1Unit, Syringe, Air And/Or Water 1Gag, Mouth 1Chisel, Bone, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	46688	Adson bone rongeur forceps, 20cm, 8"	Class I
UK	14147	EXTRAKTIONSFRÄSER Durchmesser 5,3mm, Kurz	Class IIa
UK	42468	Baby-Adson hemostatic forceps, curved 18cm, 7"	Class I
BR	10356500083	Kit de curetas Gracey M5 Nanopal cabo Z'SHAPE - H. Zepf	Class I
BR	10356500062	Brocas Cirúrgicas Diamantadas - H. Zepf	Class I
BR	10356500079	KIT DE TREFINAS PARA IMPLANTODONTIA 3D BONE RING - H. ZEPF	Class I
SA	ME0000008129SFDAA00111	Crown Ring Remover	—
SA	ME0000008129SFDAA00111	Crown Ring Remover	—

Helmut Zepf Medizintechnik GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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