Identity
- Trade Name
- Supersoft EUDAMED
- Device Name
- Silicone External Catheter EUDAMED
- Model / Reference
- 30006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716820130235 EUDAMED
- Basic UDI-DI
- 471682013693410HW EUDAMED
- Unit of Use DI
- 14716820130249 EUDAMED
- EMDN Code
- U070201 SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Supersoft by Dileh Medical supplies co., Ltd. — 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 | 471682013693410HW | Class I | Active |
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Manufacturer
- Manufacturer
- Dileh Medical supplies co., Ltd.
- EUDAMED SRN
- TW-MF-000016927
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 2778aa9a-9a4e-448d-88a1-02857c828f11 61 fields · synced Jun 18, 2026