Ultramed I.V. Infusion Set With non-vented Spike

EUDAMED

Class IIa (EU MDR)

Ref 1009

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

Identity

Trade Name: Ultramed I.V. Infusion Set With non-vented Spike EUDAMED
Device Name: Ultramed IV Infusion Set with non-vented Spike EUDAMED
I.V. INFUSION SET EUDAMED
Model / Reference: 1009 EUDAMED

Identifiers

Primary DI / UDI-DI: 06223004250125 EUDAMED
Basic UDI-DI: B-06223004250125 EUDAMED
622300425IVS1009Z3 EUDAMED
EMDN Code: A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED

Classification

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

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

Yes

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 I.V. Infusion Set With non-vented Spike by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDD, MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06223004250125	Class IIa	Active
EUDAMED	European Union	CE/MDR	B-06223004250125	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 (2)

EUDAMED fde5ed7e-657e-4424-bde2-2d30920d31bd 61 fields · synced Oct 8, 2026
EUDAMED c1e4b45d-ca04-46a3-8cdc-e7d98bbdbfe2 61 fields · synced May 17, 2026