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FRANTZ MEDICAL DEVELOPMENT, LTD.

USA · Mentor

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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

3listed device types

Class I 2Class II 0Class III 0unclassified 1

plus 3 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States3 registration records, 5 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: FRANTZ MEDICAL DEVELOPMENT, LTD. · FRANTZ MEDICAL DEVELOPMENT LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K981541	CLEARSTAR ENTERAL NUTRITION PUMP	1998-08-13
US	K905282	ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE	1991-03-19
US	K873119	FLEXIFLO COMPANION ENTERAL NUTRITION PUMP	1987-11-05
BR	80978569052	Cânula Arthrex Gemini	Class II

FRANTZ MEDICAL DEVELOPMENT, LTD.

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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