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BiliCocoon™ Bag Pad
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BCC211Ref CM201
by Neomedlight
Identity
- Trade Name
- BiliCocoon™ Bag Pad EUDAMEDFDA UDICareMin650 ™ Oral Pad EUDAMED
- Generic Name
- Blanket/pad infant phototherapy unit FDA UDI
- Device Name
- BiliCocoon™ Bag Pad EUDAMEDCareMin650 Oral Pad EUDAMED
- Model / Reference
- BCC211 EUDAMEDFDA UDICM201 EUDAMED
Identifiers
- Catalog Number
- BCC211 FDA UDI
- Primary DI / UDI-DI
- 03760012570249 EUDAMED03760012570065 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760012570249 EUDAMEDB-03760012570065 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 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
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™ Bag Pad by Neomedlight — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760012570249 | 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 1a8fa34c-0445-4aba-a0a6-d49d81a7f58b 61 fields · synced Jul 9, 2026
- EUDAMED 2b5f050a-b37e-49fd-bfdc-5c2dc3ae0028 61 fields · synced May 19, 2026
- FDA UDI 7b46778e-baa7-4972-872a-dae8ae16bb62 35 fields · synced May 30, 2026