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Manifold w/7.6F, 2 Way, PSF

EUDAMED

Class IIa (EU MDR)

Ref AV0079Model (H) Ventilation Circuit

by GaleMed Corporation

Identity

Trade Name
Manifold w/7.6F, 2 Way, PSF EUDAMED
Device Name
Reusable Manifold EUDAMED
Model / Reference
(H) Ventilation Circuit EUDAMED
AV0079 EUDAMED

Identifiers

Primary DI / UDI-DI
04710810119255 EUDAMED
Basic UDI-DI
471081008RNH58L EUDAMED
EMDN Code
R02010101 BREATHING CIRCUITS, W/O WATER TRAP 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

Manifold w/7.6F, 2 Way, PSF 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 5da931df-eeda-480c-89d9-e389fffed13f 61 fields · synced Jun 18, 2026