Identity
- Trade Name
- BILECLIPSE, 50 PACK EUDAMEDBiliChek FDA UDI
- Generic Name
- Transcutaneous bilirubinometer FDA UDI
- Device Name
- BilEclipse Phototherapy Protective Patch EUDAMEDBilEclipse Phototherapy Protective Patch is a single use accessory of BiliChek Non-Invasive Bilirubin Analyzer intended for use as a target window when non-invasive transcutaneous measurement of neonatal bilirubin levels is required. The device is intended to interact with patient intact skin only. FDA UDI
- Model / Reference
- B800-11 EUDAMEDBILECLIPSE, 50 PACK FDA UDI
- Description
- BilEclipse Phototherapy Protective Patch is a single use accessory of BiliChek Non-Invasive Bilirubin Analyzer intended for use as a target window when non-invasive transcutaneous measurement of neonatal bilirubin levels is required. The device is intended to interact with patient intact skin only. FDA UDI
Identifiers
- Catalog Number
- B800-11 FDA UDI
- Primary DI / UDI-DI
- 30884838051752 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM776TW EUDAMED
- Unit of Use DI
- 00884838051751 EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- Z12080410 TRANSCUTANEOUS BILIRUBINOMETERS EUDAMED
- GMDN Term
- Transcutaneous bilirubinometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Austria 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bileclipse, 50 Pack by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0884838BM776TW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 18914c48-8598-48a9-beb7-51e9d0b55432 61 fields · synced Jun 18, 2026
- FDA UDI 3b946232-673d-44bd-ac75-d46a71ba4baa 35 fields · synced May 30, 2026