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
- Manufacturer
- nice Neotech Medical Systems Pvt. Ltd.,
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 | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-300/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇹🇷 Türkiye
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