Accufuser Soft

EUDAMED

Class IIb (EU MDR)

Ref ABS2500XL-NModel ABS2500XLRef CTS0040S-NModel CTS0040SRef ABS1000S-NModel ABS1000SRef CTS0010SRef CTS0050XS-NModel CTS0050XSRef CTS0100LRef CTS0040XLRef ABS2500M-NModel ABS2500MRef CTS0100L-NRef CTS0040L-NModel CTS0040LRef CTS0200LRef CTS0100SRef CTS0020XSRef CTS0030XLRef CTS0020SRef ABS1000MRef ABS1000XSRef CTS0100MRef CTS0040MRef CTS0050SRef CTS0010LRef ABS1500L-NModel ABS1500LRef ABS0500LRef CTS0040XSRef ABS1000XLRef ABS2500LRef ABS2000L-NModel ABS2000LRef CTS0100XSRef ABS0500XS-NModel ABS0500XSRef ABS1500XLRef CTS0020S-NRef CTS0040XS-NRef ABS2000SRef ABS0400XLRef ABS0500XLRef CTS0010XSRef ABS1500M-NModel ABS1500MRef CTS0020XLRef ABS1000XL-NRef ABS0500S-NModel ABS0500SRef CTS0080XLRef ABS2000XL-NModel ABS2000XLRef CTS0020L-NModel CTS0020LRef CTS0010MRef CTS0100XLRef CTS0100XL-NRef CTS0050XL-NModel CTS0050XLRef CTS0005XS-NModel CTS0005XS

by Woo Young Medical Co., Ltd.

Identity

Device Name: Accufuser Soft EUDAMED
Model / Reference: ABS2500XL EUDAMED
ABS2500XL-N EUDAMED
CTS0040S EUDAMED
CTS0040S-N EUDAMED
ABS1000S EUDAMED
ABS1000S-N EUDAMED
CTS0010S EUDAMED
CTS0050XS EUDAMED
CTS0050XS-N EUDAMED
CTS0100L EUDAMED
CTS0040XL EUDAMED
ABS2500M EUDAMED
ABS2500M-N EUDAMED
CTS0100L-N EUDAMED
CTS0040L EUDAMED
CTS0040L-N EUDAMED
CTS0200L EUDAMED
CTS0100S EUDAMED
CTS0020XS EUDAMED
CTS0030XL EUDAMED
CTS0020S EUDAMED
ABS1000M EUDAMED
ABS1000XS EUDAMED
CTS0100M EUDAMED
CTS0040M EUDAMED
CTS0050S EUDAMED
CTS0010L EUDAMED
ABS1500L EUDAMED
ABS1500L-N EUDAMED
ABS0500L EUDAMED
CTS0040XS EUDAMED
ABS1000XL EUDAMED
ABS2500L EUDAMED
ABS2000L EUDAMED
ABS2000L-N EUDAMED
CTS0100XS EUDAMED
ABS0500XS EUDAMED
ABS0500XS-N EUDAMED
ABS1500XL EUDAMED
CTS0020S-N EUDAMED
CTS0040XS-N EUDAMED
ABS2000S EUDAMED
ABS0400XL EUDAMED
ABS0500XL EUDAMED
CTS0010XS EUDAMED
ABS1500M EUDAMED
ABS1500M-N EUDAMED
CTS0020XL EUDAMED
ABS1000XL-N EUDAMED
ABS0500S EUDAMED
ABS0500S-N EUDAMED
CTS0080XL EUDAMED
ABS2000XL EUDAMED
ABS2000XL-N EUDAMED
CTS0020L EUDAMED
CTS0020L-N EUDAMED
CTS0010M EUDAMED
CTS0100XL EUDAMED
CTS0100XL-N EUDAMED
CTS0050XL EUDAMED
CTS0050XL-N EUDAMED
CTS0005XS EUDAMED
CTS0005XS-N EUDAMED

Identifiers

Primary DI / UDI-DI: D-ABS2500XLNK6 EUDAMED
D-CTS0040SN4L EUDAMED
D-ABS1000SNPW EUDAMED
D-CTS0010SEV EUDAMED
D-CTS0050XSNZ7 EUDAMED
D-CTS0100LEH EUDAMED
D-CTS0050XS5L EUDAMED
D-CTS0040XL4X EUDAMED
D-ABS2500MNRG EUDAMED
D-CTS0100LN3E EUDAMED
D-CTS0040LN3X EUDAMED
D-CTS0200LEQ EUDAMED
D-CTS0100SEX EUDAMED
D-CTS0020XS4X EUDAMED
D-CTS0030XL4Q EUDAMED
D-CTS0020SF2 EUDAMED
D-ABS1000M3X EUDAMED
D-ABS1000XSQP EUDAMED
D-CTS0100MEK EUDAMED
D-CTS0040MEY EUDAMED
D-CTS0050SFH EUDAMED
D-CTS0010LEF EUDAMED
D-ABS1500LNQY EUDAMED
D-ABS0500L4M EUDAMED
D-CTS0040XS5D EUDAMED
D-ABS1000XLQ9 EUDAMED
D-ABS2500L5B EUDAMED
D-ABS2000LNPN EUDAMED
D-CTS0100XS4U EUDAMED
D-ABS0500XSNJR EUDAMED
D-ABS1500XLRY EUDAMED
D-CTS0020SN46 EUDAMED
D-CTS0020XSNY6 EUDAMED
D-ABS2000S4N EUDAMED
D-ABS0400XLR8 EUDAMED
D-ABS0500XLRK EUDAMED
D-CTS0040SFC EUDAMED
D-CTS0010XS4Q EUDAMED
D-ABS1500MNR3 EUDAMED
D-CTS0020XL4H EUDAMED
D-ABS1000XLNGL EUDAMED
D-ABS0500SNR8 EUDAMED
D-CTS0080XL5T EUDAMED
D-ABS0500S53 EUDAMED
D-ABS2000XLNH5 EUDAMED
D-CTS0020LN3H EUDAMED
D-CTS0010MEH EUDAMED
D-CTS0100XL4E EUDAMED
D-CTS0100XLNX8 EUDAMED
D-CTS0050XLNYJ EUDAMED
D-CTS0005XSNYK EUDAMED
Basic UDI-DI: B-ABS2500XLNK6 EUDAMED
B-CTS0040SN4L EUDAMED
B-ABS1000SNPW EUDAMED
B-CTS0010SEV EUDAMED
B-CTS0050XSNZ7 EUDAMED
B-CTS0100LEH EUDAMED
B-CTS0050XS5L EUDAMED
B-CTS0040XL4X EUDAMED
B-ABS2500MNRG EUDAMED
B-CTS0100LN3E EUDAMED
B-CTS0040LN3X EUDAMED
B-CTS0200LEQ EUDAMED
B-CTS0100SEX EUDAMED
B-CTS0020XS4X EUDAMED
B-CTS0030XL4Q EUDAMED
B-CTS0020SF2 EUDAMED
B-ABS1000M3X EUDAMED
B-ABS1000XSQP EUDAMED
B-CTS0100MEK EUDAMED
B-CTS0040MEY EUDAMED
B-CTS0050SFH EUDAMED
B-CTS0010LEF EUDAMED
B-ABS1500LNQY EUDAMED
B-ABS0500L4M EUDAMED
B-CTS0040XS5D EUDAMED
B-ABS1000XLQ9 EUDAMED
B-ABS2500L5B EUDAMED
B-ABS2000LNPN EUDAMED
B-CTS0100XS4U EUDAMED
B-ABS0500XSNJR EUDAMED
B-ABS1500XLRY EUDAMED
B-CTS0020SN46 EUDAMED
B-CTS0020XSNY6 EUDAMED
B-ABS2000S4N EUDAMED
B-ABS0400XLR8 EUDAMED
B-ABS0500XLRK EUDAMED
B-CTS0040SFC EUDAMED
B-CTS0010XS4Q EUDAMED
B-ABS1500MNR3 EUDAMED
B-CTS0020XL4H EUDAMED
B-ABS1000XLNGL EUDAMED
B-ABS0500SNR8 EUDAMED
B-CTS0080XL5T EUDAMED
B-ABS0500S53 EUDAMED
B-ABS2000XLNH5 EUDAMED
B-CTS0020LN3H EUDAMED
B-CTS0010MEH EUDAMED
B-CTS0100XL4E EUDAMED
B-CTS0100XLNX8 EUDAMED
B-CTS0050XLNYJ EUDAMED
B-CTS0005XSNYK EUDAMED
EMDN Code: A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED

Classification

Device Class: Class IIb EUDAMED
Market of Registration: France 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

Yes

EUDAMEDEUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Elastomeric infusion pump system

Accufuser Soft by Woo Young Medical 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
Neofuser Twin — S&S Med Co.,Ltd. · Class IIb
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

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-ABS2500XLNK6	Class IIb	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Woo Young Medical Co., Ltd.
EUDAMED SRN: KR-MF-000022134
Authorised Representative: Obelis s.a. BE-AR-000000106

Sources (51)

EUDAMED 252fdcd5-a007-4852-bc20-3725b0905e96 61 fields · synced Oct 5, 2026
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