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ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Adult Standard)

EUDAMED

Class IIa (EU MDR)

Ref 2008-01Model ULTRAMED OXYGEN FACE MASK Model ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Adult Standard)

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

Identity

Trade Name
ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Adult Standard) EUDAMED
Device Name
ULTRAMED OXYGEN FACE MASK EUDAMED
Model / Reference
ULTRAMED OXYGEN FACE MASK EUDAMED
2008-01 EUDAMED
ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Adult Standard) EUDAMED

Identifiers

Primary DI / UDI-DI
06223004253348 EUDAMED
Basic UDI-DI
622300425OFM2004TL EUDAMED
B-06223004253348 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

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Adult Standard) by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDD, MDR — listed…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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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 (2)

  • EUDAMED 6624cf09-7322-4f12-b3b3-c67305a44232 61 fields · synced Oct 6, 2026
  • EUDAMED 6effcf32-cae7-47e3-8a7e-ba4f07315477 61 fields · synced May 19, 2026