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BM Reinforced Tracheostomy Tube with Evacuation Lumen

EUDAMED

Class IIa (EU MDR)

Ref 228 50 00 2Model Reinforced Tracheostomy Tube with Evacuation Lumen, ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 9.5mm

by Bonree Medical Co., Ltd.

Identity

Trade Name
BM Reinforced Tracheostomy Tube with Evacuation Lumen EUDAMED
Device Name
Tracheostomy Tubes EUDAMED
Model / Reference
Reinforced Tracheostomy Tube with Evacuation Lumen, ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 9.5mm EUDAMED
228 50 00 2 EUDAMED

Identifiers

Primary DI / UDI-DI
06972091927587 EUDAMED
Basic UDI-DI
697209192RTE35MN EUDAMED
Direct Marketing DI
06972091927587 EUDAMED
EMDN Code
R0105020201 TRACHEOSTOMIC CANNULAS, CUFFED, REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED

Classification

Device Class
Class IIa 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 Reinforced Tracheostomy Tube with Evacuation Lumen by Bonree Medical 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

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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 56b0ca4d-1ef5-4ceb-8733-f619db693875 61 fields · synced Jun 19, 2026