Identity
- Trade Name
- Bilical, 50 Pack EUDAMEDBiliChek FDA UDI
- Generic Name
- Transcutaneous bilirubinometer FDA UDI
- Device Name
- BiliCal Tips EUDAMEDBiliCal BiliChek Disposable Calibration Tip is a single use accessory of BiliChek Non-Invasive Bilirubin Analyzer intended to calibrate the filtered light of the BiliChek Non-Invasive Bilirubin Analyzer 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
- B800-50 EUDAMEDBilical, 50 Pack FDA UDI
- Description
- BiliCal BiliChek Disposable Calibration Tip is a single use accessory of BiliChek Non-Invasive Bilirubin Analyzer intended to calibrate the filtered light of the BiliChek Non-Invasive Bilirubin Analyzer 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
- B800-50 FDA UDI
- Primary DI / UDI-DI
- 00884838096578 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM341SP EUDAMED
- Unit of Use DI
- 30884838096579 EUDAMED
- FDA Product Code
- MQM FDA UDI
- EMDN Code
- Z12080410 TRANSCUTANEOUS BILIRUBINOMETERS EUDAMED
- GMDN Term
- Transcutaneous bilirubinometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.1113 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bilical, 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 | 0884838BM341SP | 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 fcc33778-5bda-4025-9efd-6a35e7c8a700 61 fields · synced Jul 9, 2026
- FDA UDI cd05c9a5-279b-4230-bd45-4652bcedf086 35 fields · synced May 30, 2026