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Nuwellis, Inc.

USA · Eden Prairie

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Singapore, Hong Kong — 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

6listed device types

Class I 0Class II 6Class III 0

plus 4 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class III 1

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 States4 registration records, 2 510(k), 0 PMA

Manufacturer names merged into this page: Nuwellis, Inc. · NUWELLIS INC.

Business registration

CIK: 0001506492
Registration status: Active
Listing status: Listed (NUWE)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12023 · K233515

12025 · K252226

FDA listed device types

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use 1Midline Catheter 1Catheter, Hemodialysis, Non-Implanted 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Catheter, Hemodialysis, Implanted 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252226	Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)	2025-08-13
US	K233515	Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)	2023-12-26

Nuwellis, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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