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HEBUMEDICAL GMBH

Germany · Tuttlingen Baden-Wurttemberg

✓ Record-verifiedregistrations found in 7 markets

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

pendingnot queried

USUnited StatesFDA openFDA

227listed device types

Class I 207Class II 20Class III 0

plus 233 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 5

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 11IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 2b 1

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 States233 registration records, 1 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Manufacturer names merged into this page: HEBUMEDICAL GMBH · HEBUmedical GmbH

FDA 510(k) clearances by year

12013 · K123077

FDA listed device types

showing 8 of 227

Chisel, Surgical, Manual 1Knife, Nasal 1Accessories, Implant, Dental, Endosseous 1Rod, Measuring Ear 1Stripper, Surgical 1Halter, Head, Traction 1Gag, Mouth 1Chisel, Middle-Ear 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123077	VASCULAR CLAMPS	2013-05-14
BR	80285220025	ESTABILIZADOR DINÂMICO SAFE-HAND	Class I
BR	81897710009	Instrumentais Cirurgicos Articulados Não Cortantes Fentex	Class I
BR	81897710010	Instrumentais Cirurgicos Não Articulados Cortantes Fentex	Class I
SA	ME0000009975SFDAA00005	Finocchietto- rib spreader	—
SA	ME0000009975SFDAA00004	vascular scissors	—

HEBUMEDICAL GMBH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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