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No. 11 0498 CN/NB

Certificate
IVDD Annex IV Section 4·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs

200234 QS/NB

Certificate
MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·4 Basic UDI-DIs

200234QS/NB

Certificate
MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

21 0212 QS/NB

Certificate
MDD Annex II (excluding section 4)·M.I.Tech Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·12 Basic UDI-DIs

190004 QS/NB

Certificate
MDD Annex II (excluding section 4)·ICZ.HEA a.s.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

170222 QS/NB

Certificate
MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

JYV CONCEPT

Importer
🇫🇷 France·2 Manufacturers

SPS MEDICAL

Importer
🇫🇷 France·1 Manufacturer

Sterimed s.r.o.

Importer
🇨🇿 Czechia·1 Manufacturer

Media, Culture, Ex Vivo, Tissue And Cell

FDA classification
FDA Class 2 ·Media, Culture, Ex Vivo, Tissue And Cell

Fujirebio Europe N.V.

Importer
🇧🇪 Belgium·7 Manufacturers

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Alto Abdominal Stent Graft System

Lutech

FDA UDI
LUTECH INDUSTRIES INC·B299780MPMO20·Multi-parameter patient monitor. 780-M-pMO2

Capsule Vitals Plus

FDA UDI
Philips North America LLC·03615040001725·Vitals Plus Backpack Oximeter Nellcor Capno Masimo

Capsule Vitals Plus

FDA UDI
Philips North America LLC·03615040002395·Vitals Plus Backpack Capno Masimo

Lutech

FDA UDI
LUTECH INDUSTRIES INC·B299760NC0·Multi-parameter patient monitor. 760-N-C

PROPAQ M

FDA UDI
Zoll Medical Corporation·00847946002121·Defibrillator ,MAIN ASSY, 12LD, SPO2, CO2, NIBP...

Lutech

FDA UDI
LUTECH INDUSTRIES INC·B299780MPMP0·Multi-parameter patient monitor. 780-M-pM-P

X SERIES

FDA UDI
Zoll Medical Corporation·00847946029951·MAIN ASSY, X SERIES ADVANCED, MONITOR/DEFIBRILL...

X SERIES

FDA UDI
Zoll Medical Corporation·00847946045449·X SERIES ADVANCED, 12 LEAD W/INTERP, PACE, SPO2...