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Non-rebreathing Valve Complete with 60cmH2O

EUDAMED

Class IIa (EU MDR)

Ref RE-21165

by Besmed Health Business Corp.

Identity

Trade Name
Non-rebreathing Valve Complete with 60cmH2O EUDAMED
Device Name
Non-Rebreathing Valve complete with 60 cmH2O EUDAMED
Model / Reference
RE-21165 EUDAMED

Identifiers

Primary DI / UDI-DI
04716770211657 EUDAMED
Basic UDI-DI
B-04716770211657 EUDAMED
EMDN Code
R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Slovenia EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Pulmonary resuscitator, manual, single-use

Non-rebreathing Valve Complete with 60cmH2O by Besmed Health Business Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary resuscitator, manual, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
TW-MF-000007246
Authorised Representative
Casus Europe B.V. NL-AR-000037688

Sources (1)

  • EUDAMED 05e5635e-88ab-4ae2-a764-6cb05b921173 61 fields · synced Oct 6, 2026