Eu Mdd Eu Md Class 2b On The Market 🇮🇳 India

Operah Plus

Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
08908003989075
Basic UDI-DI Code
B-08908003989075
Reference
nice 5000 RP
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

The model nice 5000 RP has Infant Radiant Warmer with T-piece resuscitator and Phototherapy for warming pre-mature babies, neonates and infant with a body weight of up to 10 Kg to maintain the body temperature at the desired level; designed to provide light of suitable wave-length and intensity for the treatment of hyperbilirubinemia and also to provide the controlled suction and oxygen based manual resuscitation facilities necessary in helping the new born baby with breathing difficulties survive the immediate post- natal period.

CND Nomenclature Codes

Code Description
Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT
R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER
Z12080407 NEONATAL RADIANT WARMERS

Certificates

Type Number
MDD Annex II (excluding section 4) 1434-MDD-300/2021

Available In Countries

🇹🇷 Türkiye

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