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BiliCocoon™ Light Box
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BCC010
by Neomedlight
Identity
- Trade Name
- BiliCocoon™ Light Box EUDAMEDFDA UDI
- Generic Name
- Blanket/pad infant phototherapy unit FDA UDI
- Device Name
- BiliCocoon™ Light Box EUDAMED
- Model / Reference
- BCC010 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- BCC010 FDA UDI
- Primary DI / UDI-DI
- 03760012570102 EUDAMED03760012570003 FDA UDI
- Basic UDI-DI
- B-03760012570102 EUDAMED
- 510(k) Number
- K163526 FDA UDI
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Blanket/pad infant phototherapy unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5700 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BiliCocoon™ Light Box by Neomedlight — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760012570102 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Neomedlight
- EUDAMED SRN
- FR-MF-000004044
Sources (2)
- EUDAMED bc7d70a7-56c9-44cd-9735-cd0372fd6cb3 61 fields · synced Aug 4, 2026
- FDA UDI 34205b29-6b60-4858-a750-61c757b8eeb1 35 fields · synced May 30, 2026