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BM Nelaton Catheters
EUDAMEDClass I (EU MDR)
Ref 30108002Model Length: Male: 40cm: 6Fr ;8Fr ;10Fr ;12Fr ;14Fr ;16Fr ;18Fr ;20Fr ;22Fr. Length: Female: 20cm: 6Fr ;8Fr ;10Fr ;12Fr ;14Fr ;16Fr ;18Fr ;20Fr ;22Fr
Identity
- Trade Name
- BM Nelaton Catheters EUDAMED
- Device Name
- Nelaton Catheters EUDAMED
- Model / Reference
- Length: Male: 40cm: 6Fr ;8Fr ;10Fr ;12Fr ;14Fr ;16Fr ;18Fr ;20Fr ;22Fr. Length: Female: 20cm: 6Fr ;8Fr ;10Fr ;12Fr ;14Fr ;16Fr ;18Fr ;20Fr ;22Fr EUDAMED30108002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382611600 EUDAMED
- Basic UDI-DI
- 697209192NLTN23QX EUDAMED
- Direct Marketing DI
- 06942382611600 EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
BM Nelaton Catheters by Bonree Medical 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 | 697209192NLTN23QX | Class I | Active |
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Manufacturer
- Manufacturer
- Bonree Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017844
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 18d123f0-8446-45ba-a2ab-84012759aba6 61 fields · synced Sep 17, 2026