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Silicone Katheter voor Zelf-Katherisatie (Type Man)
EUDAMEDClass I (EU MDR)
Ref 04-5116HRef 04-5112H
Identity
- Trade Name
- Silicone Katheter voor Zelf-Katherisatie (Type Man) EUDAMED
- Device Name
- Self-Catheterization Set EUDAMED
- Model / Reference
- 04-5116H EUDAMED04-5112H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187220605 EUDAMED04542187220582 EUDAMED
- Basic UDI-DI
- 45421870001896 EUDAMED
- EMDN Code
- U010199 URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Silicone Katheter voor Zelf-Katherisatie (Type Man) by Create Medic 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 | 45421870001896 | Class I | Active |
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Manufacturer
- Manufacturer
- Create Medic Co., Ltd.
- EUDAMED SRN
- JP-MF-000010849
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3d30d88c-f290-4711-a571-7b02d0a02424 61 fields · synced Jul 16, 2026
- EUDAMED eec0064a-a4ee-45a0-b25d-1f43021600b5 61 fields · synced May 18, 2026