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BiliCocoon™ Nest System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BCC101Ref CM311Model CM211
by Neomedlight
Identity
- Trade Name
- BiliCocoon™ Nest System EUDAMEDFDA UDICareMin650 ™ Derma Sleeve EUDAMED
- Generic Name
- Blanket/pad infant phototherapy unit FDA UDI
- Device Name
- BiliCocoon™ Nest System EUDAMEDCareMin650 ™ Oral Sleeve EUDAMED
- Model / Reference
- BCC101 EUDAMEDFDA UDICM211 EUDAMEDCM311 EUDAMED
Identifiers
- Catalog Number
- BCC101 FDA UDI
- Primary DI / UDI-DI
- 03760012570171 EUDAMED03760012570010 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760012570171 EUDAMED376001257CM650Sleeve7A EUDAMED
- 510(k) Number
- K163526 FDA UDI
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMEDZ12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Blanket/pad infant phototherapy unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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™ Nest System by Neomedlight — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-03760012570171 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-03760012570171 | 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 (3)
- EUDAMED 57af8ddf-b4d8-4cb1-9441-f6e10f79781e 61 fields · synced Jun 19, 2026
- EUDAMED 8ecb7c84-653a-4a8e-a218-08c2aac199e2 61 fields · synced May 18, 2026
- FDA UDI b3e3ca30-9e76-4cf1-9e7f-605521536cfd 35 fields · synced May 30, 2026