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BiliCocoon™ Bag System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BCC201Ref CM301
by Neomedlight
Identity
- Trade Name
- BiliCocoon™ Bag System EUDAMEDFDA UDICareMin650 ™ Derma Pad EUDAMED
- Generic Name
- Blanket/pad infant phototherapy unit FDA UDI
- Device Name
- BiliCocoon™ Bag System EUDAMEDCareMin650 ™ Derma Pad EUDAMED
- Model / Reference
- BCC201 EUDAMEDFDA UDICM301 EUDAMED
Identifiers
- Catalog Number
- BCC201 FDA UDI
- Primary DI / UDI-DI
- 03760012570126 EUDAMED03760012570058 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760012570126 EUDAMED376001257CM301UR EUDAMED
- 510(k) Number
- K163526 FDA UDI
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMEDZ12040202 PHOTOTHERAPY EQUIPMENT 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
Unlock the full potential of your patients with the BiliCocoon Bag System, a revolutionary medical device designed to simplify and streamline clinical workflows.
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-03760012570126 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-03760012570126 | 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 33ced629-85b1-4c94-8795-b7e730f82bdf 61 fields · synced Jul 13, 2026
- EUDAMED 35346b1f-61e4-4d93-9d5c-527b26676f5d 61 fields · synced May 17, 2026
- FDA UDI c9c021e5-eb38-4a12-a647-45308ee42318 35 fields · synced May 30, 2026