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Accufuser
EUDAMEDClass IIb (EU MDR)
Ref F0130MRef SE5015SRef NSG10008MRef B2010XLRef T4015XLRef F0020SRef NSG4060SRef NSE10015LRef F0040LRef M2008SRef P5015MRef SE1015SRef NSD10015MRef SE10030MRef SP2060SRef SE1030MRef SD8030TRef NSE5060MRef Accufuser PlusModel SD8008SRef ST8030XLRef SM0530MRef C1000XLRef SE1008SRef SB1008TRef B0508MRef F0010MRef NSE5030LRef SP5015TRef SD10008SRef SP2015TRef NSE5008SRef T1015SRef NSD10008MRef SD1008TRef SE4060TRef SG2015TRef T8015LRef NSE2008SRef T0508SRef SG8030MRef SP2015LRef SD4060MRef SE2060XLRef SG2015MRef SG2008SRef NSD8030LRef NSD10030LRef NSE8060TRef ST10015LRef SP0508SRef SD5060M
Identity
- Device Name
- Accufuser EUDAMEDAccufuser Plus EUDAMED
- Model / Reference
- F0130M EUDAMEDSE5015S EUDAMEDNSG10008M EUDAMEDB2010XL EUDAMEDT4015XL EUDAMEDF0020S EUDAMEDNSG4060S EUDAMEDNSE10015L EUDAMEDF0040L EUDAMEDM2008S EUDAMEDP5015M EUDAMEDSE1015S EUDAMEDNSD10015M EUDAMEDSE10030M EUDAMEDSP2060S EUDAMEDSE1030M EUDAMEDSD8030T EUDAMEDNSE5060M EUDAMEDSD8008S EUDAMEDAccufuser Plus EUDAMEDST8030XL EUDAMEDSM0530M EUDAMEDC1000XL EUDAMEDSE1008S EUDAMEDSB1008T EUDAMEDB0508M EUDAMEDF0010M EUDAMEDNSE5030L EUDAMEDSP5015T EUDAMEDSD10008S EUDAMEDSP2015T EUDAMEDNSE5008S EUDAMEDT1015S EUDAMEDNSD10008M EUDAMEDSD1008T EUDAMEDSE4060T EUDAMEDSG2015T EUDAMEDT8015L EUDAMEDNSE2008S EUDAMEDT0508S EUDAMEDSG8030M EUDAMEDSP2015L EUDAMEDSD4060M EUDAMEDSE2060XL EUDAMEDSG2015M EUDAMEDSG2008S EUDAMEDNSD8030L EUDAMEDNSD10030L EUDAMEDNSE8060T EUDAMEDST10015L EUDAMEDSP0508S EUDAMEDSD5060M EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-F0130MVN EUDAMEDD-SE5015SQC EUDAMEDD-NSG10008M2K EUDAMEDD-B2010XL94 EUDAMEDD-T4015XLL9 EUDAMEDD-F0020SVN EUDAMEDD-NSG4060SJ6 EUDAMEDD-NSE10015LZ8 EUDAMEDD-F0040LVJ EUDAMEDD-M2008SZM EUDAMEDD-P5015M3G EUDAMEDD-SE1015SNY EUDAMEDD-NSD10015MYR EUDAMEDD-SE10030M2X EUDAMEDD-SP2060SU4 EUDAMEDD-SE1030MNF EUDAMEDD-SD8030TQV EUDAMEDD-NSE5060MHB EUDAMEDD-SD8008SR4 EUDAMEDD-ST8030XLHJ EUDAMEDD-SM0530MSF EUDAMEDD-C1000XL8Z EUDAMEDD-SE1008SP4 EUDAMEDD-SB1008TMX EUDAMEDD-B0508MV7 EUDAMEDD-F0010MV5 EUDAMEDD-NSE5030LGS EUDAMEDD-SP5015TUV EUDAMEDD-SD10008S33 EUDAMEDD-SP2015TTU EUDAMEDD-NSE5008SHH EUDAMEDD-T1015S44 EUDAMEDD-NSD10008MYV EUDAMEDD-SD1008TNR EUDAMEDD-SE4060TQD EUDAMEDD-SG2015TQ7 EUDAMEDD-T8015L63 EUDAMEDD-NSE2008SGG EUDAMEDD-T0508S4Y EUDAMEDD-SG8030MRN EUDAMEDD-SP2015LTC EUDAMEDD-SD4060MPJ EUDAMEDD-SE2060XL7S EUDAMEDD-SG2015MPR EUDAMEDD-SG2008SQ9 EUDAMEDD-NSD8030LHE EUDAMEDD-NSD10030LYJ EUDAMEDD-NSE8060TJS EUDAMEDD-ST10015LAZ EUDAMEDD-SP0508SUB EUDAMEDD-SD5060MPV EUDAMED
- Basic UDI-DI
- B-F0130MVN EUDAMEDB-SE5015SQC EUDAMEDB-NSG10008M2K EUDAMEDB-B2010XL94 EUDAMEDB-T4015XLL9 EUDAMEDB-F0020SVN EUDAMEDB-NSG4060SJ6 EUDAMEDB-NSE10015LZ8 EUDAMEDB-F0040LVJ EUDAMEDB-M2008SZM EUDAMEDB-P5015M3G EUDAMEDB-SE1015SNY EUDAMEDB-NSD10015MYR EUDAMEDB-SE10030M2X EUDAMEDB-SP2060SU4 EUDAMEDB-SE1030MNF EUDAMEDB-SD8030TQV EUDAMEDB-NSE5060MHB EUDAMEDB-SD8008SR4 EUDAMEDB-ST8030XLHJ EUDAMEDB-SM0530MSF EUDAMEDB-C1000XL8Z EUDAMEDB-SE1008SP4 EUDAMEDB-SB1008TMX EUDAMEDB-B0508MV7 EUDAMEDB-F0010MV5 EUDAMEDB-NSE5030LGS EUDAMEDB-SP5015TUV EUDAMEDB-SD10008S33 EUDAMEDB-SP2015TTU EUDAMEDB-NSE5008SHH EUDAMEDB-T1015S44 EUDAMEDB-NSD10008MYV EUDAMEDB-SD1008TNR EUDAMEDB-SE4060TQD EUDAMEDB-SG2015TQ7 EUDAMEDB-T8015L63 EUDAMEDB-NSE2008SGG EUDAMEDB-T0508S4Y EUDAMEDB-SG8030MRN EUDAMEDB-SP2015LTC EUDAMEDB-SD4060MPJ EUDAMEDB-SE2060XL7S EUDAMEDB-SG2015MPR EUDAMEDB-SG2008SQ9 EUDAMEDB-NSD8030LHE EUDAMEDB-NSD10030LYJ EUDAMEDB-NSE8060TJS EUDAMEDB-ST10015LAZ EUDAMEDB-SP0508SUB EUDAMEDB-SD5060MPV EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMEDA05010102 ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Elastomeric infusion pump system
Accufuser 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-F0130MVN | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-F0130MVN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Woo Young Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000022134
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (51)
- EUDAMED 039460ee-6999-42e6-bb9c-053902ca4c7d 61 fields · synced Oct 6, 2026
- EUDAMED 060e8e56-cefa-448a-bab6-7473a6dd8f70 61 fields · synced May 11, 2026
- EUDAMED 14463bdc-06a1-4a85-8656-6e2670d169e0 61 fields · synced May 11, 2026
- EUDAMED 1fa19e77-caa6-4bee-90ce-b475a13aef44 61 fields · synced May 11, 2026
- EUDAMED 2d14e027-164b-4500-a5c9-67b8cb845f41 61 fields · synced May 11, 2026
- EUDAMED 31b5ca93-45af-43bf-81b9-f995d670f2e9 61 fields · synced May 11, 2026
- EUDAMED 41be8efb-bebd-41e5-97c9-5b0366a707ec 61 fields · synced May 11, 2026
- EUDAMED 53a9a0fb-d2e7-4650-a1f9-a4b84ef3dda2 61 fields · synced May 11, 2026
- EUDAMED 576163a8-3dbe-4d85-946b-d567eb62eeb3 61 fields · synced May 11, 2026
- EUDAMED 585ee52f-3ba4-4e5a-a00e-5a2773a64fe6 61 fields · synced May 11, 2026
- EUDAMED 5f7b79ec-0145-4486-855c-b77336a8b543 61 fields · synced May 11, 2026
- EUDAMED 671c7d96-2784-4c6c-ad1e-4c9e8e028ce1 61 fields · synced May 11, 2026
- EUDAMED 6e4c8f21-ad79-48b8-886e-0626593e2a0e 61 fields · synced May 11, 2026
- EUDAMED 7cc095bc-3432-4670-ae1d-731cc7735b60 61 fields · synced May 11, 2026
- EUDAMED 804f3623-9170-4104-8bb4-d83273ecbf3b 61 fields · synced May 11, 2026
- EUDAMED 88fa8a88-cb17-4e8b-9b1a-813a8dbf8457 61 fields · synced May 11, 2026
- EUDAMED a41d427d-5f67-4b8d-ba24-51d6656b2174 61 fields · synced May 11, 2026
- EUDAMED a50f82e1-3889-42df-aeb0-9db1588e3b00 61 fields · synced May 11, 2026
- EUDAMED aa95cdc1-cbb4-4580-8710-78b9865e67de 61 fields · synced May 11, 2026
- EUDAMED cabde507-f760-42e6-9d04-36fc7e3c9489 61 fields · synced May 11, 2026
- EUDAMED cf0d5b25-b9d4-48a8-9181-6df4150d9f39 61 fields · synced May 11, 2026
- EUDAMED d7de9728-8490-4fa9-b5e4-f10fdd8c02af 61 fields · synced May 11, 2026
- EUDAMED e0d8b366-7c9f-42e2-b260-c252818b8e0c 61 fields · synced May 11, 2026
- EUDAMED e0d91b03-4067-42f8-997d-10034fad9ad5 61 fields · synced May 11, 2026
- EUDAMED fa93045c-d1ae-48c5-a8bc-f0b0a1493741 61 fields · synced May 11, 2026
- EUDAMED fd6138a2-304b-42da-979d-60a40623303f 61 fields · synced May 11, 2026
- EUDAMED 03e44cce-2f9d-4d03-b40b-fb38a38bb828 61 fields · synced May 11, 2026
- EUDAMED 115c386a-bc2b-44df-b698-ccd7456f7b30 61 fields · synced May 11, 2026
- EUDAMED 1539600e-326f-4323-b72a-8e480e9c0d4f 61 fields · synced May 11, 2026
- EUDAMED 150d173c-4aa6-4374-9374-af0b8d45a275 61 fields · synced May 11, 2026
- EUDAMED 17f0c0bd-fcc1-4e6f-a8da-2cc1909edc3a 61 fields · synced May 11, 2026
- EUDAMED 17b0814d-f7bd-4f4b-8bb1-02b6085af528 61 fields · synced May 11, 2026
- EUDAMED 40748a77-47ee-4bba-ac6e-8790c827da9a 61 fields · synced May 16, 2026
- EUDAMED b2a25da4-e646-4eca-a0d6-fe40dc42d2f2 61 fields · synced May 16, 2026
- EUDAMED b78b7002-189d-424c-83f9-e999f673e219 61 fields · synced May 16, 2026
- EUDAMED 3f9b9c19-d99d-4622-b23b-5383c7612132 61 fields · synced May 16, 2026
- EUDAMED 48eb409c-0b03-43fb-a7b9-043f1fa67112 61 fields · synced May 16, 2026
- EUDAMED c2b6ce02-f95c-4976-88b0-1a531e66b1ad 61 fields · synced May 16, 2026
- EUDAMED 47646107-e4c3-4496-bb8c-859cf37fd6c5 61 fields · synced May 16, 2026
- EUDAMED 00f63f71-2dd7-49ec-ad16-01cf0b63b207 61 fields · synced May 16, 2026
- EUDAMED 9a278876-38a1-4694-9812-0c33533a9c8b 61 fields · synced May 16, 2026
- EUDAMED cef48264-e53f-4dcf-90a2-0d9ada2ed063 61 fields · synced May 16, 2026
- EUDAMED a5c37b2d-6365-4506-ab62-bf46efac2da7 61 fields · synced May 16, 2026
- EUDAMED 7bd686ae-f43a-4783-bbe8-9d4f59bffa4b 61 fields · synced May 16, 2026
- EUDAMED 9a61d0be-1b81-43f5-917c-5aaf3715d140 61 fields · synced May 16, 2026
- EUDAMED c43de81a-7d81-494a-bacd-8aa19e3e927b 61 fields · synced May 16, 2026
- EUDAMED bc1a4c20-ba8a-4f4f-a332-4f9cbb3556fc 61 fields · synced May 16, 2026
- EUDAMED 73f7ac22-56b7-4175-bb9f-2e35151f09f5 61 fields · synced May 16, 2026
- EUDAMED 0b56e664-f11d-4907-bd6b-303fa10aeed0 61 fields · synced May 16, 2026
- EUDAMED ece3bf8f-4064-4d26-9da0-050695d88bbc 61 fields · synced May 16, 2026
- EUDAMED 2e2a558b-c4d6-48bd-8ac1-671d0853f328 61 fields · synced May 16, 2026