20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: India
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GREEN EDGE VENTURES
FDA registration
GREEN EDGE VENTURES·1 product·🇮🇳 India
AKAS MEDICAL EQUIPMENT
Manufacturer
🇮🇳 India·5 Basic UDI-DIs·5 Devices·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 and INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
AKAS INFUSIONS
Device
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·On the market·1 country
AKAS INFUSIONS
Device
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·On the market·1 country
AKAS INFUSIONS
Device
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·On the market·1 country
AKAS INFUSIONS
Device
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·On the market·1 country
AKAS INFUSIONS
Device
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·On the market·1 country
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
Volumetric Infusion Pump
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·1 device
Volumetric Infusion Pump
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·1 device
Syringe Infusion Pump
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·1 device
Syringe Infusion Pump
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·1 device
Syringe Infusion Pump
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AKAS MEDICAL EQUIPMENT·1 device
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
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024