Identity
- Trade Name
- Nelaton Catheter EUDAMED
- Device Name
- urethral catheter EUDAMED
- Model / Reference
- FR14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958627537116 EUDAMED
- Basic UDI-DI
- B-06958627537116 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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: Indwelling urethral drainage balloon catheter, non-antimicrobial
Nelaton Catheter by Ningbo Greetmed Medical Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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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-06958627537116 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Greetmed Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000009634
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED acb1bf7f-9ef8-449e-9f16-4c66dc1467cc 61 fields · synced Jul 16, 2026