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Non-Invasive Ventilator

EUDAMED

Class IIa (EU MDR)

Ref RV30FM2Ref RV50SU2Ref R-80SRef R-90S

by BMC Medical Co., Ltd.

Identity

Trade Name
Non-Invasive Ventilator EUDAMED
Device Name
Non-Invasive Ventilator EUDAMED
Model / Reference
RV30FM2 EUDAMED
RV50SU2 EUDAMED
R-80S EUDAMED
R-90S EUDAMED

Identifiers

Primary DI / UDI-DI
06948538365779 EUDAMED
06948538365809 EUDAMED
06948538365915 EUDAMED
06948538365908 EUDAMED
Basic UDI-DI
69485383RIV01ZL EUDAMED
Direct Marketing DI
06948538365779 EUDAMED
06948538365809 EUDAMED
06948538365915 EUDAMED
06948538365908 EUDAMED
EMDN Code
Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Non-Invasive Ventilator by BMC 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
BMC Medical Co., Ltd.
EUDAMED SRN
CN-MF-000010157
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED ec6981c9-4cff-4fe9-9fc3-bde4d7f51747 61 fields · synced Aug 2, 2026
  • EUDAMED 0decf320-e161-4478-a3a5-634a947d8df7 61 fields · synced May 17, 2026
  • EUDAMED 6ea399a0-5584-4e42-8119-e95a7e5f0b59 61 fields · synced May 18, 2026
  • EUDAMED 68f4eb1d-6b62-498f-a74f-364d87a54858 61 fields · synced May 18, 2026