Eu Mdd
Eu Md Class 2b
On The Market
🇻🇳 Vietnam
Dolphin CPAP
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 111720643880
- Basic UDI-DI Code
- B-111720643880
- Reference
- CDP-10000
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
Additional Description
The Bubble CPAP Therapy provided by the device is indicated for the respiratory support of spontaneously breathing neonatal patients with mild to severe idiopathic respiratory distress syndrome (RDS), mild to severe apnea, atelectasis, hyaline membrane disease (HMD), meconium aspiration syndrome (MAS), transient tachypnea of the neonate (TTN) or lung edema. The device is indicated for use in a hospital setting. The device is not indicated for use with patients whose upper airways have been bypassed.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1203020408 | PULSE OXIMETERS |
| Z12030102 | CONTINUOUS POSITIVE PRESSURE EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2019-MDD/QS-093 | 3EC International a.s. | Expired |
Available In Countries
🇮🇹 Italy
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