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Giraffe PT Light Meter ( English Unit )
EUDAMEDFDA UDIClass I (EU MDR)
Ref D16103000
Identity
- Trade Name
- Giraffe PT Light Meter ( English Unit ) EUDAMEDGiraffe PT Light Meter FDA 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
- D16103000 EUDAMEDFDA 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
- 5697449 FDA UDI
- Primary DI / UDI-DI
- 07640158711514 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
- Germany 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
Giraffe PT Light Meter ( English Unit ) 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 dee8150a-2464-4d13-ba56-de5d9d0c2e29 61 fields · synced Jul 9, 2026
- FDA UDI 7bb7181a-e8d1-4ac0-94c8-d27271c8924d 34 fields · synced May 30, 2026