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Pfm Medical, Inc.

Germany · Carlsbad

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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

38listed device types

Class I 15Class II 19Class III 4

plus 76 registration records and 20 510(k), 5 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

39registered devices

Class I 11Class II 28

49 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

23 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2a 1

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 States76 registration records, 20 510(k), 5 PMA, 1 excluded

Brazil39 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: PFM Medical GmbH · pfm medical mepro gmbh · PFM Medical, Inc · pfm medical cpp SA · PFM MEDICAL, INC. · PFM MEDICAL MEPRO GMBH

FDA 510(k) clearances by year

12004

42007

12008

22009

12010

12011

12012

12013

12014

12018

12019

12020

12022

12023

22025

FDA listed device types

showing 8 of 38

Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Apparatus, Suction, Patient Care 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Bottle, Collection, Vacuum 1Peritoneal Dialysis Administration Kit 1Midline Catheter 1Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling 1Catheter, Embolectomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242763	JetCan® Pro Safety Huber Needle	2025-05-02
US	K241278	ASEPT® Glide Peritoneal Drainage System	2025-01-14
US	K221779	ASEPT Peritoneal Drainage System	2023-05-02
BR	82673289027	Redon-Drains with Pre Attached Needle	Class II
BR	82673289028	REDON-MINI-SETS (reservatório)	Class II
BR	82673289029	LOW VACUUM SYSTEM COM TROCAR	Class II

Pfm Medical, 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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