Identity
- Trade Name
- Brief EUDAMED
- Device Name
- Silicone External Catheter EUDAMED
- Model / Reference
- 31013 EUDAMED31037 EUDAMED31044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716820131287 EUDAMED04716820131355 EUDAMED04716820131409 EUDAMED
- Basic UDI-DI
- 471682013693410HW EUDAMED
- Unit of Use DI
- 14716820131291 EUDAMED14716820131369 EUDAMED14716820131413 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
Brief 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 (3)
- EUDAMED 4357fcf5-2282-4302-aa5a-3239d6604e46 61 fields · synced Jul 31, 2026
- EUDAMED cf03da88-3919-44ab-9721-67bb1219e3af 61 fields · synced May 16, 2026
- EUDAMED 964f6746-b7bc-41f1-b3a1-c3eb907feb58 61 fields · synced May 17, 2026