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Freudenberg Medical Ireland Limited

Ireland · Leitrim Leitrim

✓ Record-verifiedregistrations found in 4 markets

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

31listed device types

Class I 13Class II 15Class III 2unclassified 1

plus 58 registration records and 3 510(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

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States58 registration records, 3 510(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 Ireland Limited · Freudenberg Medical Inc, · Freudenberg Medical LLC

FDA 510(k) clearances by year

22019 · K192422

12024 · K240763

FDA listed device types

showing 8 of 31

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 Ireland Limited

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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