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
- 08908003989068
- Basic UDI-DI Code
- B-08908003989068
- Reference
- nice 5000 R
- 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 R has Infant Radiant Warmer with T-piece resuscitator 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 and is designed to provide the controlled suction and oxygen based manual resuscitation facilities necessary in helping the new born baby with breathing difficulties to survive the immediate post-natal period.
CND Nomenclature Codes
| Code | Description |
|---|---|
| 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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