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ReadiCath All Silicone Reusable Catheter ・Male L Type
EUDAMEDClass I (EU MDR)
Ref 8000015799HRef 8000015984H
Identity
- Trade Name
- ReadiCath All Silicone Reusable Catheter ・Male L Type EUDAMED
- Device Name
- Self-Catheterization Set EUDAMED
- Model / Reference
- 8000015799H EUDAMED8000015984H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187214628 EUDAMED04542187216479 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
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
ReadiCath All Silicone Reusable Catheter ・Male L Type 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 f81f8593-ef68-487a-8aa1-3427f8fe0662 61 fields · synced Jul 19, 2026
- EUDAMED f57e47a0-0157-4b35-9169-2dc1c3d6f47a 61 fields · synced May 19, 2026