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Silicone Katheter voor Zelf-Katherisatie (Type Vrouw)
EUDAMEDClass I (EU MDR)
Ref 04-5212HRef 04-5210HRef 04-5214H
Identity
- Trade Name
- Silicone Katheter voor Zelf-Katherisatie (Type Vrouw) EUDAMED
- Device Name
- Self-Catheterization Set EUDAMED
- Model / Reference
- 04-5212H EUDAMED04-5210H EUDAMED04-5214H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187220629 EUDAMED04542187220612 EUDAMED04542187220636 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 Vrouw) 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 (3)
- EUDAMED a30a6548-856c-4c5c-89f8-ce18f2e3b903 61 fields · synced Aug 4, 2026
- EUDAMED a0c1c3a1-cbe4-481d-83a9-48a11da57acb 61 fields · synced May 18, 2026
- EUDAMED 23542c08-2880-4d24-9d2e-6e40551a7ee2 61 fields · synced May 18, 2026