Eu Mdd
Eu Md Class 2a
No Longer On The Market
🇮🇳 India
Bilitron Sky 2006
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08908025930000
- Basic UDI-DI Code
- B-08908025930000
- Reference
- FANEM-CTL-2006
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- No Longer On The Market
- Manufacturer
- Fanem Medical Devices India Private Limited
Additional Description
Bilitron Sky 2006 is commonly used in the treatment of neonatal hyperbilirubinemia, subjecting the patient to radiation exposure cantered on the blue range of the visible light spectrum for a certain amount of time, defined by the medical protocol in service.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12080401 | PAEDIATRIC PHOTOTHERAPY EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 10000320442-PA-NA-IND | DNV Product Assurance AS | Expired |
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