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MEQU A/S

Matched from indexed company URL: MEQU A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30325806283032580628MEQU A/S1N2026-01-01Fruebjergvej 3 Copenhagen Hovedstaden DK 2100

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3311401539222038K260988°M Warmer System with °M StationLGZ2026-04-24
3311401827557987K232107°M Warmer SystemLGZ2024-05-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LGZ22026-04-24

PMN#

GUDID#

°M Warmer System - Starter Kit+ - The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack+ (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140046) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).

Mequ A/S

2024-10-30

°M Warmer System - Starter Kit - The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.The °MEQU °M Warmer System Starter Kit consists of three components: The °M Warmer (a single-patient use, disposable IV fluid / blood warmer unit – primary DI number 05700002076816), the Power Pack (a multi-patient, reusable, rechargeable battery pack for powering the °M Warmer – primary DI number 05745000140039) and the Charger (a reusable charger for recharging the battery pack – primary DI number 05700002076847).

Mequ A/S

2024-10-30