Neofuser TN

EUDAMED

Class IIb (EU MDR)

Ref X10-TNRef VX214-TNRef S50-TN

by S&S Med Co., Ltd.

Identity

Trade Name: Neofuser TN EUDAMED
Neofuser EUDAMED
Device Name: Single Use Infusion Pump EUDAMED
Model / Reference: X10-TN EUDAMED
VX214-TN EUDAMED
S50-TN EUDAMED

Identifiers

Primary DI / UDI-DI: 08800331531318 EUDAMED
08800027782864 EUDAMED
08800331530885 EUDAMED
Basic UDI-DI: B-08800331531318 EUDAMED
B-08800027782864 EUDAMED
B-08800331530885 EUDAMED
EMDN Code: A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
A05010201 ELASTOMERIC SYSTEMS - VARIABLE 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 TN 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-08800331531318	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 5b68728b-c7bd-425d-8b18-662974d0a0be 61 fields · synced Aug 4, 2026
EUDAMED 1ac5d93e-245d-451c-8d27-82fce61d2bf8 61 fields · synced May 17, 2026
EUDAMED 609e3787-69ae-4e8a-99fa-9d97f201a8ca 61 fields · synced May 18, 2026