Identity
- Trade Name
- Supersoft EUDAMED
- Device Name
- Silicone External Catheter EUDAMED
- Model / Reference
- 30013 EUDAMED30044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716820130280 EUDAMED04716820130402 EUDAMED
- Basic UDI-DI
- 471682013693410HW EUDAMED
- Unit of Use DI
- 14716820130294 EUDAMED14716820130416 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
No
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 (2)
- EUDAMED 64bc7d77-d958-490f-9057-d4691edfe6b5 61 fields · synced Jul 9, 2026
- EUDAMED 8ed739a3-7e75-40fc-9b44-f3efe2ae017d 61 fields · synced May 18, 2026