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BiliCocoon™ Bag Disposable
EUDAMEDFDA UDIClass I (EU MDR)
Ref BCC221Model BCC121Ref CM010
by Neomedlight
Identity
- Trade Name
- BiliCocoon™ Bag Disposable EUDAMEDFDA UDICareMin650 ™ Lightbox EUDAMED
- Generic Name
- Basic bed sheet, single-use FDA UDI
- Device Name
- BiliCocoon™ Nest Disposable EUDAMEDCareMin650 ™ Lightbox EUDAMED
- Model / Reference
- BCC121 EUDAMEDBCC221 EUDAMEDFDA UDICM010 EUDAMED
Identifiers
- Catalog Number
- BCC221 FDA UDI
- Primary DI / UDI-DI
- 03760012570133 EUDAMED03760012570089 EUDAMEDFDA UDI
- Basic UDI-DI
- 376001257BCCDisposableR4 EUDAMEDB-03760012570089 EUDAMED
- 510(k) Number
- K163526 FDA UDI
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080485 NEONATOLOGY INSTRUMENTS - CONSUMABLES EUDAMEDZ12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Basic bed sheet, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass 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
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™ Bag Disposable by Neomedlight — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 376001257BCCDisposableR4 | Class I | Active |
| 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 (3)
- EUDAMED c9fbfeb1-bafb-4705-8d7a-4f0ad8c32d51 61 fields · synced Jun 18, 2026
- EUDAMED dc17c032-a7a3-4603-ad4c-94084b9b3aae 61 fields · synced May 18, 2026
- FDA UDI e388f353-554f-45e0-9577-87a82b7383dc 35 fields · synced May 30, 2026