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ReadiCath All Silicone Reusable Catheter Set ・Female Type
EUDAMEDClass I (EU MDR)
Ref 04-4116HRef 04-4110HRef 04-4112H
Identity
- Trade Name
- ReadiCath All Silicone Reusable Catheter Set ・Female Type EUDAMED
- Device Name
- Self-Catheterization Set EUDAMED
- Model / Reference
- 04-4116H EUDAMED04-4110H EUDAMED04-4112H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187215557 EUDAMED04542187215526 EUDAMED04542187215533 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 Set ・Female 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 (3)
- EUDAMED f5c231a6-e2cb-4705-bb2a-10a9a1ce59f9 61 fields · synced Jul 26, 2026
- EUDAMED 403de30a-c176-4d03-bbf8-9a17d08cdb4d 61 fields · synced May 18, 2026
- EUDAMED 4e6f5194-8f78-4000-8330-373867d1b0e6 61 fields · synced May 19, 2026