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BiliCocoon™ Fixation System
EUDAMEDFDA UDIClass I (EU MDR)
Ref BCC301
by Neomedlight
Identity
- Trade Name
- BiliCocoon™ Fixation System EUDAMEDFDA UDI
- Generic Name
- Blanket/pad infant phototherapy unit FDA UDI
- Device Name
- BiliCocoon™ Fixation System EUDAMED
- Model / Reference
- BCC301 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- BCC301 FDA UDI
- Primary DI / UDI-DI
- 03760012570218 EUDAMED03760012570096 FDA UDI
- Basic UDI-DI
- 376001257BCC301PU EUDAMED
- 510(k) Number
- K163526 FDA UDI
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080499 NEONATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Blanket/pad infant phototherapy unit FDA UDI
Classification
- Device Class
- Class I 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
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
No
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
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™ Fixation System by Neomedlight — 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 | 376001257BCC301PU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neomedlight
- EUDAMED SRN
- FR-MF-000004044
Sources (2)
- EUDAMED 0f705be6-deb9-4fdb-8b3c-81a81ad9da80 61 fields · synced Jun 18, 2026
- FDA UDI 2cacae33-4d1e-4080-87ad-161a9d7f3f2f 35 fields · synced May 30, 2026