Identity
- Trade Name
- nelaton catheter EUDAMED
- Device Name
- nelaton catheter EUDAMED
- Model / Reference
- FR16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977177661034 EUDAMED
- Basic UDI-DI
- 697717766113QC EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
nelaton catheter by ChangShu Super Medical Equipment Co., Ltd. — Class IIa — 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 | 697717766113QC | Class IIa | Active |
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Manufacturer
- Manufacturer
- ChangShu Super Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000040937
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8b40280a-8a63-4a6d-858f-584ed80112e2 61 fields · synced Jun 18, 2026