← Back to catalogue
bili-hut nest and mattress consumables
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0133FDK5
Identity
- Trade Name
- bili-hut™ fully disposable convenience kit (5-Pack) FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- bili-hut nest and mattress consumables EUDAMED
- Model / Reference
- 0133FDK5 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810101280542 EUDAMEDFDA UDI
- Basic UDI-DI
- 0810101280133JN EUDAMED
- Direct Marketing DI
- 00810101280542 EUDAMED
- 510(k) Number
- K190899 FDA UDI
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Overhead infant phototherapy unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5700 FDA UDI
- Market of Registration
- Netherlands 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
bili-hut nest and mattress consumables by Little Sparrows Technologies, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0810101280133JN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Little Sparrows Technologies, Inc.
- EUDAMED SRN
- US-MF-000040265
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 0219ca87-3cb3-40b8-85df-2717401baff4 61 fields · synced Jun 19, 2026
- FDA UDI ecc86e30-5fd5-413d-a119-9d0daac4ee13 33 fields · synced May 30, 2026