Identity
- Trade Name
- PURE CATH EUDAMED
- Device Name
- Self-Catheterization Set EUDAMED
- Model / Reference
- 800-001-1323 EUDAMED800-000-9913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187214093 EUDAMED04542187214062 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
Pure Cath 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 ce08ea42-4b81-4acf-8029-d16fe6968573 61 fields · synced Jul 9, 2026
- EUDAMED fea320dd-93a6-4ce8-ad6d-cdd4b95d4367 61 fields · synced May 18, 2026