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Mahe Medical GmbH

Germany · Emmingen

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, 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

76listed device types

Class I 56Class II 20Class III 0

plus 69 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 17Class II 2

27 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

Class I 2IIa 4IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

27active registrations

Class 2a 27

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 States69 registration records, 2 510(k), 0 PMA, 2 excluded

Brazil19 confirmed, 0 excluded

Manufacturer names merged into this page: MAHE MEDICAL USA · MAHE MEDICAL GMBH

FDA 510(k) clearances by year

22011 · K110655

FDA listed device types

showing 8 of 76

Electrosurgical, Cutting & Coagulation & Accessories 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Cerclage, Fixation 1Screw, Fixation, Bone 1Laparoscope, Gynecologic (And Accessories) 1Washer, Bolt Nut 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K110655	MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM	2011-10-27
US	K102845	MAHE FIXATION PLATE AND SCREW SYSTEM	2011-05-13
BR	80003890109	Instrumental para Sistema de Fixação Cervical Mahe	Class I
BR	10314809016	KIT DE LAVAGEM MAHEMEDICAL	Class II
BR	80003890110	Instrumental para Sistema de Fixação Toracolombar Mahe	Class I

Mahe Medical 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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