Steriflo Plus

EUDAMED

Class IIa (EU MDR)

Ref SS-3308Ref SS-3077Ref SS-3077 KAD

by Romsons Group Private Limited

Identity

Trade Name: STERIFLO PLUS EUDAMED
STERIFLO EUDAMED
Device Name: INFUSION SET EUDAMED
Model / Reference: SS-3308 EUDAMED
SS-3077 EUDAMED
SS-3077 KAD EUDAMED

Identifiers

Primary DI / UDI-DI: 08907265330809 EUDAMED
08907265307702 EUDAMED
08907265011029 EUDAMED
Basic UDI-DI: 8907265C014YS EUDAMED
EMDN Code: A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED

Classification

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

Clinical & Handling

Sterile

Yes

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

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Steriflo Plus by Romsons Group Private Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

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	8907265C014YS	Class IIa	Active

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Manufacturer

Manufacturer: Romsons Group Private Limited
EUDAMED SRN: IN-MF-000036506
Authorised Representative: Obelis s.a. BE-AR-000000106

Sources (3)

EUDAMED 5fb9f744-e0b4-4579-81e1-311bb36fd95e 61 fields · synced Jul 10, 2026
EUDAMED 76d63b84-135d-433a-9b5a-262ddf29d77c 61 fields · synced May 17, 2026
EUDAMED 42daaef9-19d9-4e09-8fcd-1e8844b09581 61 fields · synced May 18, 2026