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BM Disposable Air Cushion Face Masks

EUDAMED

Class IIa (EU MDR)

Ref 230 01 00 2Model Neonate, Infant, Pediatric, Small Adult, Medium Adult, Large adult, Ultra Adult

by Bonree Medical Co., Ltd.

Identity

Trade Name
BM Disposable Air Cushion Face Masks EUDAMED
Device Name
Disposable Air Cushion Face Masks EUDAMED
Model / Reference
Neonate, Infant, Pediatric, Small Adult, Medium Adult, Large adult, Ultra Adult EUDAMED
230 01 00 2 EUDAMED

Identifiers

Primary DI / UDI-DI
06942382611112 EUDAMED
Basic UDI-DI
697209192ACM30D2 EUDAMED
Direct Marketing DI
06942382611112 EUDAMED
EMDN Code
R03010101 ANAESTHETIC FACE MASKS 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

Yes

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: Anaesthesia face mask, single-use

BM Disposable Air Cushion Face Masks by Bonree Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia face mask, single-use.

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 8add8569-1b0c-4909-aa9a-b638d594b558 61 fields · synced Jun 18, 2026