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OM-2 HiO2 Mask, Child w/Tubing, PVC Bag

EUDAMED

Class IIa (EU MDR)

Ref AO0156Model (D) Oxygen TherapyRef AO0092

by GaleMed (Xiamen) Co., Ltd.

Identity

Trade Name
OM-2 HiO2 Mask, Child w/Tubing, PVC Bag EUDAMED
OM-2 HiO2 Mask, Child w/Tubing EUDAMED
Device Name
Disposable Oxygen therapy EUDAMED
Hi-Oxygen Mask EUDAMED
Model / Reference
AO0156 EUDAMED
(D) Oxygen Therapy EUDAMED
AO0092 EUDAMED

Identifiers

Primary DI / UDI-DI
06923980110870 EUDAMED
04710810106866 EUDAMED
06923980106026 EUDAMED
Basic UDI-DI
69239801ND2MFPU EUDAMED
471081008NND378 EUDAMED
EMDN Code
R03010206 MASKS WITH RESERVOIR EUDAMED
R03010201 AIR/OXYGEN MASKS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED
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

OM-2 HiO2 Mask, Child w/Tubing, PVC Bag by GaleMed (Xiamen) 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
GaleMed (Xiamen) Co., Ltd.
EUDAMED SRN
CN-MF-000020627
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 2aaa984a-ecff-4d86-a878-ded27db9d778 61 fields · synced Sep 18, 2026
  • EUDAMED a9f7b99f-03ad-45e8-b510-3af9adda2d69 61 fields · synced May 19, 2026
  • EUDAMED 509e8def-3a47-47c4-b768-f31b61157469 61 fields · synced Jul 24, 2026