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GB Libra Sheath
EUDAMEDClass I (EU MDR)
Ref GBLSS35Ref GBLSP28Ref GBLSS40Ref GBLSW35Ref GBLSS28Ref GBLSW24Ref GBLSS33Ref GBLSS24Ref GBLSP35Ref GBLSW28Ref GBLSP24Ref GBLSP33
Identity
- Trade Name
- GB Libra Sheath EUDAMED
- Device Name
- GB Libra Sheath EUDAMED
- Model / Reference
- GBLSS35 EUDAMEDGBLSP28 EUDAMEDGBLSS40 EUDAMEDGBLSW35 EUDAMEDGBLSS28 EUDAMEDGBLSW24 EUDAMEDGBLSS33 EUDAMEDGBLSS24 EUDAMEDGBLSP35 EUDAMEDGBLSW28 EUDAMEDGBLSP24 EUDAMEDGBLSP33 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060152310742 EUDAMED05060152310773 EUDAMED05060152310759 EUDAMED05060152310841 EUDAMED05060152310728 EUDAMED05060152310810 EUDAMED05060152311824 EUDAMED05060152310711 EUDAMED05060152310797 EUDAMED05060152310827 EUDAMED05060152310766 EUDAMED05060152311831 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 (12)
- EUDAMED 0d9c931b-4ae9-4025-99fa-d94fb4702b45 61 fields · synced Aug 3, 2026
- EUDAMED 88bf4f62-ff5d-4ed0-9e4a-f4560135a195 61 fields · synced May 16, 2026
- EUDAMED a0d2726f-58b6-4c83-b998-703c45ebacd5 61 fields · synced May 16, 2026
- EUDAMED ad0d6579-9966-43b2-82d0-ce6c39c06d7b 61 fields · synced May 16, 2026
- EUDAMED b3332746-581f-4ef1-9bf6-c5ce57e76a68 61 fields · synced May 16, 2026
- EUDAMED 9296a564-2c8b-4b4b-abb1-4a47ef09cdcd 61 fields · synced May 17, 2026
- EUDAMED 153e83d0-2f35-48e7-a606-29e62419b501 61 fields · synced May 17, 2026
- EUDAMED 552f4649-4d5a-408d-8382-ab8e8441e9fc 61 fields · synced May 18, 2026
- EUDAMED 03eeed3c-62e3-43f8-9f39-73dad4a7b51b 61 fields · synced May 18, 2026
- EUDAMED ec4760b2-c8ae-44bc-930f-d7b6ff0f7aea 61 fields · synced May 18, 2026
- EUDAMED 5ff78c4b-c6be-4678-bf73-df74881ddd09 61 fields · synced May 18, 2026
- EUDAMED 72cadee7-9362-4b64-aef2-fe54b6c16f97 61 fields · synced May 19, 2026