T/B/NK Lymphocyte Detection Kit(Flow Cytometry)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Qingdao Raisecare Biological Technology Co., Ltd.·1 device

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE

NSK Europe GmbH

Importer

🇩🇪 Germany·1 Manufacturer

V8800 Critical Care Ventilator

FDA registration

BEIJING AEONMED CO., LTD.·4 products·🇨🇳 China

RESMED PTY LTD.

FDA registration

RESMED PTY LTD.·4 products·🇦🇺 Australia

Vivo 55

FDA registration

BREAS MEDICAL, INC.·4 products·🇺🇸 United States

Vivo 65

FDA registration

BREAS MEDICAL AB·4 products·🇸🇪 Sweden

V8800 Critical Care Ventilator

FDA registration

Oricare Inc.·4 products·🇺🇸 United States

RESMED CORP

FDA registration

RESMED CORP·4 products·🇺🇸 United States

Vivo 65

FDA registration

BREAS MEDICAL, INC.·4 products·🇺🇸 United States

Continuous, Ventilator, Home Use

FDA classification

FDA Class 2 ·Continuous, Ventilator, Home Use

MR Buffer Solution、MR Detergent Solution、MR Na/K Check Solution

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Hangzhou Singclean Medical Products Co., Ltd.

Manufacturer

🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

1839/MDD

Certificate

MDD Annex II (excluding section 4)·NSK Dental Italy S.r.l.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·2 Basic UDI-DIs

VOCSN Patient Breathing Package

FDA UDI

VENTEC LIFE SYSTEMS, INC.·00855573007624·VOCSN Patient Breathing Package (Pediatric, Pas...

Trilogy

FDA UDI

Respironics, Inc.·00606959022683·Trilogy 200 Ventilator, International

Trilogy

FDA UDI

Respironics, Inc.·00606959022089·Trilogy 200 Ventilator, Brazil

Trilogy 100

FDA UDI

Respironics, Inc.·00606959052345·Trilogy 100 Ventilator, w/ Bluetooth, Japan

Trilogy 100

FDA UDI

Respironics, Inc.·00606959042933·Trilogy 100 Ventilator, withBluetooth, Italy

Trilogy 100

FDA UDI

Respironics, Inc.·00606959026469·Trilogy 100 Ventilator with Bluetooth, Internat...