Identity
- Trade Name
- GB Libra Sheath EUDAMED
- Device Name
- GB Libra Sheath EUDAMED
- Model / Reference
- GBLSW40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060152310858 EUDAMED
- Basic UDI-DI
- 506015231TF0009N2 EUDAMED
- EMDN Code
- U070201 SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
GB Libra Sheath by Clinisupplies GB Limited — 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 | 506015231TF0009N2 | Class I | Active |
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Manufacturer
- Manufacturer
- Clinisupplies GB Limited
- EUDAMED SRN
- GB-MF-000023993
- Authorised Representative
- MD REPS Ltd XI-AR-000040375
Sources (1)
- EUDAMED f71a3352-5b1b-41ab-9a82-f8737e441c45 61 fields · synced Jun 18, 2026