Identity
- Device Name
- LINC All Silicone EUDAMED
- Model / Reference
- Open Tip EUDAMED08452210H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060548241339 EUDAMED
- Basic UDI-DI
- B-05060548241339 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
LINC All Silicone by LINC Medical Systems Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060548241339 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LINC Medical Systems Ltd
- EUDAMED SRN
- UK-MF-000037544
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED da9e08e7-1a9b-40cd-97e8-489ed35ac7c4 61 fields · synced Jun 19, 2026