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ReadiCath All Silicone Reusable Catheter ・Female Type
EUDAMEDClass I (EU MDR)
Ref 04-5216HRef 04-5212HRef 04-5214H
Identity
- Trade Name
- ReadiCath All Silicone Reusable Catheter ・Female Type EUDAMED
- Device Name
- Self-Catheterization Set EUDAMED
- Model / Reference
- 04-5216H EUDAMED04-5212H EUDAMED04-5214H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187214666 EUDAMED04542187214642 EUDAMED04542187214659 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 ・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 f06bfedb-824c-44dc-866e-81fabb7b394f 61 fields · synced Aug 2, 2026
- EUDAMED 2b205016-3979-42ae-90dc-4c2335a256f8 61 fields · synced May 17, 2026
- EUDAMED 07a8fc49-d254-4cac-8ca4-f658bea74061 61 fields · synced May 18, 2026