← Back to catalogue

ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Neonates)

EUDAMED

Class IIa (EU MDR)

Ref 2007-03Model ULTRAMED OXYGEN FACE MASK (With Nebulizer) Model ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Neonates)

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 EUDAMED
ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Neonates) EUDAMED

Identifiers

Primary DI / UDI-DI
06223004253454 EUDAMED
Basic UDI-DI
622300425OFM2007TS EUDAMED
B-06223004253454 EUDAMED
EMDN Code
R03010201 AIR/OXYGEN MASKS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Romania EUDAMED

Clinical & Handling

Sterile

Yes

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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

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 (2)

  • EUDAMED 375e6d0e-ba5b-4b21-b8fb-ca4c1c631852 61 fields · synced Oct 6, 2026
  • EUDAMED 18ed06a4-5fb0-4be1-b335-4b4b777122f5 61 fields · synced May 17, 2026