ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Neonates)

EUDAMED

Class IIa (EU MDR)

Ref 2007-03/NModel ULTRAMED OXYGEN FACE MASK (With Nebulizer)

by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)

Identity

Trade Name: ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Neonates) EUDAMED
Device Name: ULTRAMED OXYGEN FACE MASK EUDAMED
Model / Reference: ULTRAMED OXYGEN FACE MASK (With Nebulizer) EUDAMED
2007-03/N EUDAMED

Identifiers

Primary DI / UDI-DI: 06223004254000 EUDAMED
Basic UDI-DI: 622300425OFM2007TS EUDAMED
EMDN Code: R03010201 AIR/OXYGEN MASKS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Romania EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Neonates) by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	622300425OFM2007TS	Class IIa	Active

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Manufacturer

Manufacturer: Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)
EUDAMED SRN: EG-MF-000038562
Authorised Representative: Obelis s.a. BE-AR-000000106

Sources (1)

EUDAMED a52d7c0d-6e84-4ed6-b760-6972d93f0762 61 fields · synced Oct 6, 2026