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HMEF, 22F/15M, 22/15mm

EUDAMED

Class IIa (EU MDR)

Ref AH0025Model (J) HME & Filter

by GaleMed Corporation

Identity

Trade Name
HMEF, 22F/15M, 22/15mm EUDAMED
Device Name
HMEF EUDAMED
Model / Reference
(J) HME & Filter EUDAMED
AH0025 EUDAMED

Identifiers

Primary DI / UDI-DI
04710810110795 EUDAMED
Basic UDI-DI
471081008NNJ17N EUDAMED
EMDN Code
R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS 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

HMEF, 22F/15M, 22/15mm 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 9a678697-35b1-40d6-b913-ec6ef6c72a16 61 fields · synced Jun 19, 2026