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BiliCocoon™ Nest Disposable
EUDAMEDFDA UDIClass I (EU MDR)
Ref BCC121
by Neomedlight
Identity
- Trade Name
- BiliCocoon™ Nest Disposable EUDAMEDFDA UDI
- Generic Name
- Basic bed sheet, single-use FDA UDI
- Device Name
- BiliCocoon™ Nest Disposable EUDAMED
- Model / Reference
- BCC121 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- BCC121 FDA UDI
- Primary DI / UDI-DI
- 03760012570195 EUDAMED03760012570041 FDA UDI
- Basic UDI-DI
- 376001257BCCDisposableR4 EUDAMED
- 510(k) Number
- K163526 FDA UDI
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080485 NEONATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Basic bed sheet, single-use 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BiliCocoon™ Nest Disposable 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 | 376001257BCCDisposableR4 | 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 c4939dd9-bcb5-4254-a14f-0a5ae1a61b43 61 fields · synced Jul 9, 2026
- FDA UDI 632a66d4-8b53-4b26-b2e3-51d6f3dfefc0 35 fields · synced May 29, 2026