Identity
- Device Name
- LINC All Silicone EUDAMED
- Model / Reference
- 084618101H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060548241537 EUDAMED
- Basic UDI-DI
- B-05060548241537 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON 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-05060548241537 | 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 e7c3ae36-11de-4975-9927-e9a08766d632 61 fields · synced Jun 19, 2026