Identity
- Trade Name
- BiliCare EUDAMED
- Device Name
- BiliCare EUDAMED
- Model / Reference
- 81000300. EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290015630016 EUDAMED
- Basic UDI-DI
- 7290015630810002003F EUDAMED
- EMDN Code
- Z12080410 TRANSCUTANEOUS BILIRUBINOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BiliCare by Gerium Medical Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290015630810002003F | Class I | Active |
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Manufacturer
- Manufacturer
- Gerium Medical Ltd.
- EUDAMED SRN
- IL-MF-000016697
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED ec52fc0e-e444-486d-a287-5d09c65b5ac9 61 fields · synced Jun 18, 2026