Home›USA›Medspira, LLC

Medspira, LLC

USA · Minneapolis

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel — 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

4listed device types

Class I 0Class II 4Class III 0

plus 6 registration records and 3 510(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

1 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States6 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: MEDSPIRA LLC · MEDSPIRA, LLC

FDA 510(k) clearances by year

12012 · K120088

12015 · K143031

12025 · K252605

FDA listed device types

System, Gastrointestinal Motility (Electrical) 1Coil, Magnetic Resonance, Specialty 1Monitor, Esophageal Motility, Anorectal Motility, And Tube 1Device, Biofeedback 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252605	mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)	2025-12-05
US	K143031	mcompass Biofeedback Anorectal Manometry System	2015-07-07
US	K120088	MCOMPASS ANORECTAL MANOMETRY SYSTEM	2012-03-29

Medspira, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies