Identity
- Trade Name
- Schelin Catheter EUDAMED
- Device Name
- Schelin Catheter EUDAMED
- Model / Reference
- SK812100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350081910195 EUDAMED07350081910198 EUDAMED
- Basic UDI-DI
- 0735008191SK812100YT EUDAMED
- EMDN Code
- U010206 URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Schelin Catheter by Prostalund AB — Class IIa — 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 | 0735008191SK812100YT | Class IIa | Active |
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Manufacturer
- Manufacturer
- ProstaLund AB
- EUDAMED SRN
- SE-MF-000004428
Sources (2)
- EUDAMED 2eddb384-52f9-4353-9cac-a90d081fa51c 61 fields · synced Jul 29, 2026
- EUDAMED effa9ec0-1eef-4dee-9722-1f4c4f792e6e 61 fields · synced May 19, 2026