Neofuser Nax

EUDAMED

Class IIb (EU MDR)

Ref X40-NRef G70-NRef I10-N

by S&S Med Co., Ltd.

Identity

Trade Name: Neofuser Nax EUDAMED
Device Name: Single Use Infusion Pump EUDAMED
Model / Reference: X40-N EUDAMED
G70-N EUDAMED
I10-N EUDAMED

Identifiers

Primary DI / UDI-DI: 08800027792313 EUDAMED
08800027792450 EUDAMED
08800027792047 EUDAMED
Basic UDI-DI: B-08800027792313 EUDAMED
B-08800027792450 EUDAMED
B-08800027792047 EUDAMED
EMDN Code: A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED

Classification

Device Class: Class IIb EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Elastomeric infusion pump system

Neofuser Nax by S&S Med Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Elastomeric infusion pump system.

SMARTeZ Plus-PainBloc-Fixed Flow 240-10-24h — Epic International (Thailand) Co., Ltd. · Class IIa
Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
SMARTeZ RS-General Infusion 250-500-30m with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
Halyard — Avanos Medical, Inc. · Class II
SMARTeZ RS-PainBloc-Fixed Flow Rate 120-5-24h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
SMARTeZ Pump 500-40-12.5h — Epic International (Thailand) Co., Ltd. · Class IIa
Halyard — Avanos Medical, Inc. · Class II
SMARTeZ RS-PainBloc-Fixed Flow Rate 80-5-16h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-08800027792313	Class IIb	Active

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Manufacturer

Manufacturer: S&S Med Co., Ltd.
EUDAMED SRN: KR-MF-000017308
Authorised Representative: Easy Medical Device BE-AR-000011902

Sources (3)

EUDAMED b8d76e7f-139d-43b6-881f-071bbae6a282 61 fields · synced Sep 17, 2026
EUDAMED 7014c739-5131-4d9d-a896-4e49bd2ae2d2 61 fields · synced May 17, 2026
EUDAMED 4ba61650-4c29-4320-bb62-5327e7fbd73c 61 fields · synced May 19, 2026