Identity
- Trade Name
- Bolus Gel, 10X10X0,5CM EUDAMED
- Device Name
- Bolus gel EUDAMED
- Model / Reference
- BL-9405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430003778272 EUDAMED
- Basic UDI-DI
- 5430003778Bolus10x10SE EUDAMED
- EMDN Code
- T030499 RADIOTHERAPY PROTECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Bolus Gel, 10X10X0, 5CM by Lievens-Lanckman Bv — 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 | 5430003778Bolus10x10SE | Class I | Active |
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Manufacturer
- Manufacturer
- Lievens-Lanckman Bv
- EUDAMED SRN
- BE-MF-000001979
Sources (1)
- EUDAMED 03f58d18-3d51-4136-8086-d534dd599694 61 fields · synced Jun 19, 2026