← Back to catalogue

Nebulizer Mask

EUDAMED

Class IIa (EU MDR)

Ref 10501001Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, InfantModel Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant. Nebulizer Jar: 6ml/8ml

by Bonree Medical Co., Ltd.

Identity

Trade Name
Nebulizer Mask EUDAMED
BM Nebulizer with Aerosol Masks EUDAMED
Device Name
Nebulizer with Aerosol Masks EUDAMED
Model / Reference
Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant EUDAMED
10501001 EUDAMED
Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant. Nebulizer Jar: 6ml/8ml EUDAMED

Identifiers

Primary DI / UDI-DI
06972091922780 EUDAMED
Basic UDI-DI
697209192ASM02GD EUDAMED
Direct Marketing DI
06972091922780 EUDAMED
EMDN Code
R03010301 AEROSOL THERAPY MASKS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Romania EUDAMED
Poland EUDAMED

Clinical & Handling

Sterile

No

EUDAMEDEUDAMED

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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Nebulizer Mask 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bonree Medical Co., Ltd.
EUDAMED SRN
CN-MF-000017844
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 258cc6d0-f753-49c5-9f81-efea814b14ec 61 fields · synced Jun 19, 2026
  • EUDAMED 99f440b2-556a-4df3-9f59-44d623947674 61 fields · synced Jun 19, 2026