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Freudenberg Medical Mis, Inc.

USA · Jeffersonville

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea, 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

pendingnot queried

USUnited StatesFDA openFDA

29listed device types

Class I 13Class II 14Class III 1unclassified 1

plus 54 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

26registered devices

Class I 15Class II 11

31 including historic records

SASaudi ArabiaSFDA

17registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

15 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

26active ARTG entries

Class I 14IIa 6IIb 5Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States54 registration records, 4 510(k), 0 PMA, 7 excluded

Brazil26 confirmed, 0 excluded

Saudi Arabia17 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: Freudenberg Medical, LLC · FREUDENBERG MEDICAL, LLC · Freudenberg Medical, SRL · Freudenberg Medical Inc, · Freudenberg Medical LLC

FDA 510(k) clearances by year

32019 · K192422

12024 · K240763

FDA listed device types

showing 8 of 29

Instrument, Ent Manual Surgical 1Gauge, Measuring 1Tube, Laryngectomy 1Kit, Surgical Instrument, Disposable 1System, Skin Closure 1Tape And Bandage, Adhesive 1Catheter, Nasopharyngeal 1Applicator, Absorbent Tipped, Non-Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240763	FirstFit Surgical Kit	2024-12-18
US	K192422	Steerable Introducer 12F	2019-10-04
US	K191190	Steerable Introducer	2019-08-01
BR	81591120021	Tampa com filtro de espuma HumidiFilter® ATSV II Blom Singer®	Class II
BR	81591129002	Válvula ajustável para traqueostoma ATSV II Blom Singer®	Class II
BR	81591120018	Protetores de espuma para estoma Blom Singer®	Class I
SA	ME0000009158SFDAA00001	Shower Guard	—
SA	ME0000009158SFDAA00002	TruSeal	—
CA	6899	BLOM SINGER INSUFFLATION TEST SET	Class II
CA	8813	BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS	Class II
CA	9093	BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET-STERILE	Class II

Freudenberg Medical Mis, Inc.

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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