Identity
- Trade Name
- HEKURA KATHETERSET EUDAMED
- Device Name
- Urinary catheterization kit EUDAMED
- Model / Reference
- SE1040-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955824048596 EUDAMED
- Basic UDI-DI
- 69558240SY0400100UC0011YW EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Hekura Katheterset by Conod Medical Co., Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 69558240SY0400100UC0011YW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Conod Medical Co., Limited
- EUDAMED SRN
- CN-MF-000012600
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c64c8401-2922-4185-8967-6ac69729a436 61 fields · synced Jun 18, 2026