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nelaton catheter
EUDAMEDClass I (EU MDR)
Ref HK-C02-10 middle boxModel HK-C02 FR10 middle box
Identity
- Trade Name
- nelaton catheter EUDAMED
- Device Name
- Nelaton catheter EUDAMED
- Model / Reference
- HK-C02 FR10 middle box EUDAMEDHK-C02-10 middle box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945934602375 EUDAMED
- Basic UDI-DI
- B-16945934602375 EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
nelaton catheter by Changzhou Huankang Medical Device Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16945934602375 | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Huankang Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000009030
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ee96ad23-836d-4965-b0cb-dcfd9930e7f9 61 fields · synced Oct 6, 2026