Home›Germany›Tutogen Medical GmBH

Tutogen Medical GmBH

Germany · Neunkirchen Am Brand

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Hong Kong, 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

7listed device types

Class I 0Class II 7Class III 0

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

3 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS D 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 3 2

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 States7 registration records, 2 510(k), 0 PMA

Manufacturer names merged into this page: Tutogen Medical GmBH · TUTOGEN MEDICAL GMBH

FDA 510(k) clearances by year

12000 · K991296

12008 · K073097

FDA listed device types

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 1Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed 1Dura Substitute 1Barrier, Animal Source, Intraoral 1Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery 1Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery 1Mesh, Surgical 1

Market	Identifier	Name	Class / date
US	K073097	TUTODENT DENTAL MEMBRANE	2008-05-12
US	K991296	TUTOPATCH	2000-10-06

Tutogen 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)

Similar companies