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Bm Hydrophilic Nelaton Catheters

EUDAMED

Class I (EU MDR)

Ref 31222002Model Super lubricath catheter:Male,40cm,6Fr,8Fr,10Fr,12Fr,14Fr,16Fr,18Fr,20Fr,22Fr;Female,20cm,6Fr,8Fr,10Fr,12Fr,14Fr,16Fr,18Fr,20Fr,22Fr

by Bonree Medical Co., Ltd.

Identity

Trade Name
BM HYDROPHILIC NELATON CATHETERS EUDAMED
Device Name
Nelaton Catheters EUDAMED
Model / Reference
Super lubricath catheter:Male,40cm,6Fr,8Fr,10Fr,12Fr,14Fr,16Fr,18Fr,20Fr,22Fr;Female,20cm,6Fr,8Fr,10Fr,12Fr,14Fr,16Fr,18Fr,20Fr,22Fr EUDAMED
31222002 EUDAMED

Identifiers

Primary DI / UDI-DI
06942382611945 EUDAMED
Basic UDI-DI
697209192NLTL23QM EUDAMED
Direct Marketing DI
06942382611945 EUDAMED
EMDN Code
U01010501 NELATON CATHETERS, 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 Hydrophilic 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

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Manufacturer

EUDAMED SRN
CN-MF-000017844
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 2ba995eb-fb2c-40af-92b3-49c227958a90 61 fields · synced Oct 6, 2026