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BiliWrap
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 820000000Ref 820000412Ref 820000460Ref 820000420
Identity
- Trade Name
- BiliWrap EUDAMEDBiliWrap Wrapper EUDAMED
- Device Name
- BiliWrap , Phototherapy system EUDAMEDBiliWrap Wrappers EUDAMED
- Model / Reference
- 820000000 EUDAMED820000412 EUDAMED820000460 EUDAMED820000420 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290015630054 EUDAMED07290015630108 EUDAMED07290015630092 EUDAMED07290015630085 EUDAMED
- Basic UDI-DI
- 729001563082000000058 EUDAMED72900156308200004015W EUDAMED
- Direct Marketing DI
- 07290015630061 EUDAMED
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMEDT030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
BiliWrap by Gerium Medical Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243372 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 729001563082000000058 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gerium Medical Ltd.
- EUDAMED SRN
- IL-MF-000016697
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (5)
- EUDAMED cf8382f0-3e87-439e-90df-a7a99275c0f7 61 fields · synced Jul 30, 2026
- EUDAMED 46a490a1-8328-430f-ab6b-353f6ae29a41 61 fields · synced May 16, 2026
- EUDAMED 49fa1225-8142-4250-a79a-ae86fca36723 61 fields · synced May 18, 2026
- EUDAMED 19cd3624-42c2-4e5a-935f-1f447290f993 61 fields · synced May 19, 2026
- FDA 510(k) K243372 1 fields · synced May 18, 2026