Identity
- Trade Name
- neoBLUE Radiometer EUDAMEDFDA UDI
- Generic Name
- Blue light radiometer FDA UDI
- Device Name
- Blue light radiometer EUDAMEDBlue light radiometer: An instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm (i.e., blue) during bilirubinemia treatment for newborns and infants FDA UDI
- Model / Reference
- D162136000 EUDAMEDD16236000 FDA UDI
- Description
- Blue light radiometer: An instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm (i.e., blue) during bilirubinemia treatment for newborns and infants FDA UDI
Identifiers
- Catalog Number
- D16236000 FDA UDI
- Primary DI / UDI-DI
- 07640158712146 EUDAMEDFDA UDI
- Basic UDI-DI
- 76401587148Y EUDAMED
- FDA Product Code
- JJQ FDA UDI
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMED
- GMDN Term
- Blue light radiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2300 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
neoBLUE Radiometer by Derungs Licht AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76401587148Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Derungs Licht AG
- EUDAMED SRN
- CH-MF-000015827
- Authorised Representative
- Derungs Medical GmbH DE-AR-000033841
Sources (2)
- EUDAMED c7a12277-0aec-419e-9e8f-403529910df7 61 fields · synced Aug 2, 2026
- FDA UDI d60bde20-d7a2-4010-9e04-d02e3c21b862 34 fields · synced May 30, 2026