Identity
- Trade Name
- BiliWrap Wrapper EUDAMED
- Device Name
- BiliWrap Wrappers EUDAMED
- Model / Reference
- 820000403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290015630078 EUDAMED
- Basic UDI-DI
- 72900156308200004015W EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Wrapper 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 | 72900156308200004015W | 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 14d2e40b-2d86-4c8d-9638-81c26d0bb68e 61 fields · synced Jun 19, 2026