DTM Natura d.o.o.

Authorized representative

🇸🇮 Slovenia

GTM Solution GmbH

Authorized representative

🇩🇪 Germany

2019/MDD

Certificate

MDD Annex II (excluding section 4)·MONTEFARMACO OTC SPA·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·9 Basic UDI-DIs

0425-MED-004106-00

Certificate

MDD Annex II (excluding section 4)·MONTEFARMACO OTC SPA·ICIM S.P.A.·2 Basic UDI-DIs

0425-MED-004179-OO

Certificate

MDD Annex V·MONTEFARMACO OTC SPA·ICIM S.P.A.·1 Basic UDI-DI

0425-MED-004179-00

Certificate

MDD Annex V·MONTEFARMACO OTC SPA·ICIM S.P.A.·1 Basic UDI-DI

1919/MDD

Certificate

MDD Annex V·MONTEFARMACO OTC SPA·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·4 Basic UDI-DIs

Transport Medium, Notified Per The Vtm Guidance

FDA classification

FDA Class 1 ·Transport Medium, Notified Per The Vtm Guidance

Sonewa GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

FDA classification

FDA Class 2 ·Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Ventilator, Emergency, Manual (Resuscitator)

FDA classification

FDA Class 2 ·Ventilator, Emergency, Manual (Resuscitator)

Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450790·

Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450455·

Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450479·

PLEGIOX Heat Exchanger with Cardioplegia

FDA UDI

Maquet Cardiopulmonary AG·04037691180038·The PLEGIOX cardioplegia heat exchanger is used...

PLEGIOX Cardioplegia Heat Exchanger

FDA UDI

Maquet Cardiopulmonary AG·04037691229591·PLEGIOX Heat Exchanger, SOFTLINE coated, Steril...

Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450820·

Curaplex

FDA UDI

BOUND TREE MEDICAL, LLC·00815277021500·FBI m9 Medical Refill Kit 2014

Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450837·

NA

FDA UDI

Maquet Cardiopulmonary AG·04037691873077·Holding Clamp for Oxygenator QUADROX-iR