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MR-100 Intake Outer Housing

EUDAMED

Class IIa (EU MDR)

Ref AR0014Model (L) Resuscitator

by GaleMed Corporation

Identity

Trade Name
MR-100 Intake Outer Housing EUDAMED
Device Name
Reusable Valve EUDAMED
Model / Reference
(L) Resuscitator EUDAMED
AR0014 EUDAMED

Identifiers

Primary DI / UDI-DI
04710810081736 EUDAMED
Basic UDI-DI
471081008RNLVAY EUDAMED
Direct Marketing DI
04710810081736 EUDAMED
EMDN Code
R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Netherlands 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

MR-100 Intake Outer Housing by GaleMed Corporation — 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
GaleMed Corporation
EUDAMED SRN
TW-MF-000022411
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED 93f3a2d6-dff0-4967-b361-d539bf686baf 61 fields · synced Jul 24, 2026