Identity
- Trade Name
- Katheter-Set S - 1 EUDAMED
- Device Name
- Care set Urinary catheterization EUDAMED
- Model / Reference
- 3311 EUDAMED4788182 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04052366901763 EUDAMED
- Basic UDI-DI
- 40495003311K9 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- A MediSet is the compilation of defined components used to perform a medical care. The components are single-used products and are used together to perform a medical care. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Device sterilization/disinfection container, reusable
Katheter-Set S - 1 by Paul Hartmann Ag — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
- SM - LIPO PANTY CHEVILLES COUPE TAILLE NOIR AVEC TROUS RECOUVERTS SUR MESURE — MEDICAL Z · Class I
- APTUS — Medartis Inc. · Class I
- APTUS — Medartis Inc. · Class II
- INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM — DAUD JEE MFG. CO · Class I
- Breastform Cover Right Size 03 (478/ 482) — Trulife · Class I
- NCB® Periprosthetic Plate System — Zimmer, Inc. · Class I
- NTOC cassette — NTOC medische techniek B.V · Class I
- MIRABOR-CA (12 BURS)- — Hager Worldwide, Inc. · Class I
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 | 40495003311K9 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paul Hartmann Ag
- EUDAMED SRN
- DE-PR-000019925
Sources (1)
- EUDAMED 3f5537cb-4c20-4ff0-a84a-166130ccabaf 61 fields · synced Jun 18, 2026