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Self-Catheterization Set (Female Type)
EUDAMEDClass I (EU MDR)
Ref 04-4114Ref 04-4112Ref 04-4110Ref 04-4116
Identity
- Trade Name
- Self-Catheterization Set (Female Type) EUDAMED
- Device Name
- Self-Catheterization Set EUDAMED
- Model / Reference
- 04-4114 EUDAMED04-4112 EUDAMED04-4110 EUDAMED04-4116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187216660 EUDAMED04542187216653 EUDAMED04542187216646 EUDAMED04542187216677 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
Self-Catheterization 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 (4)
- EUDAMED 0362c3db-f61f-4f7e-b34c-96573329658e 61 fields · synced Aug 2, 2026
- EUDAMED 832679a4-103f-4bdb-8577-c619f7b5e8de 61 fields · synced May 16, 2026
- EUDAMED b8c83245-0362-4917-88fb-7e46909538d5 61 fields · synced May 17, 2026
- EUDAMED 9337466d-65e9-428d-abc7-997d1ece42a7 61 fields · synced May 18, 2026