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ROCKWELL MEDICAL

USA · Wixom

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

1listed device types

Class I 0Class II 1Class III 0

plus 12 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

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 States12 registration records, 7 510(k), 0 PMA

Manufacturer names merged into this page: ROCKWELL MEDICAL

Same-named companies — This database also contains companies with near-identical names: Rockwell Medical Supply, Rockwell Medical Technologies, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Business registration

Legal name: ROCKWELL MEDICAL, INC.
CIK: 0001041024
Registration status: Active
Listing status: Listed (RMTI)

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160847	Rockwell Medical CitraPure Acid Concetrate	2016-10-20
US	K062399	ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE	2006-11-17
US	K023985	ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE	2003-02-28

ROCKWELL MEDICAL

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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