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Accufuser CTx
EUDAMEDClass IIb (EU MDR)
Ref CT0200LRef CT0100LRef CT0100XLRef CT0010LRef CT0015LRef CT0010SRef CT0050LRef CT0040SRef CT0100SRef CT0020SRef CT0020MRef CT0080XLRef CT0200XLRef CT0040MRef CT0040LRef CT0005MRef CT0050M
Identity
- Device Name
- Accufuser CTx EUDAMED
- Model / Reference
- CT0200L EUDAMEDCT0100L EUDAMEDCT0100XL EUDAMEDCT0010L EUDAMEDCT0015L EUDAMEDCT0010S EUDAMEDCT0050L EUDAMEDCT0040S EUDAMEDCT0100S EUDAMEDCT0020S EUDAMEDCT0020M EUDAMEDCT0080XL EUDAMEDCT0200XL EUDAMEDCT0040M EUDAMEDCT0040L EUDAMEDCT0005M EUDAMEDCT0050M EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CT0200LKL EUDAMEDD-CT0100LKD EUDAMEDD-CT0100XL4G EUDAMEDD-CT0010LKB EUDAMEDD-CT0015LKS EUDAMEDD-CT0010SKR EUDAMEDD-CT0050LKX EUDAMEDD-CT0040SL8 EUDAMEDD-CT0100SKT EUDAMEDD-CT0020SKW EUDAMEDD-CT0020MKJ EUDAMEDD-CT0080XL5V EUDAMEDD-CT0200XL4T EUDAMEDD-CT0040MKU EUDAMEDD-CT0040LKS EUDAMEDD-CT0005MKP EUDAMEDD-CT0050MKZ EUDAMED
- Basic UDI-DI
- B-CT0200LKL EUDAMEDB-CT0100LKD EUDAMEDB-CT0100XL4G EUDAMEDB-CT0010LKB EUDAMEDB-CT0015LKS EUDAMEDB-CT0010SKR EUDAMEDB-CT0050LKX EUDAMEDB-CT0040SL8 EUDAMEDB-CT0100SKT EUDAMEDB-CT0020SKW EUDAMEDB-CT0020MKJ EUDAMEDB-CT0080XL5V EUDAMEDB-CT0200XL4T EUDAMEDB-CT0040MKU EUDAMEDB-CT0040LKS EUDAMEDB-CT0005MKP EUDAMEDB-CT0050MKZ 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
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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 CTx 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-CT0200LKL | 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 (17)
- EUDAMED bec0ab15-21f5-42fa-8511-7cfacc200462 61 fields · synced Oct 6, 2026
- EUDAMED a9f5a694-dd01-4ed4-a714-8d95eb2286ac 61 fields · synced May 16, 2026
- EUDAMED 6482bb9e-2e87-4cfc-8bee-768ec2ecb790 61 fields · synced May 16, 2026
- EUDAMED 1bf69d3a-72b6-4c12-a9b3-bae7b14a5f90 61 fields · synced May 17, 2026
- EUDAMED bdbce09a-4274-4471-96d5-4ca316e28dbf 61 fields · synced May 17, 2026
- EUDAMED 2f1385a9-e992-4ad6-baa5-b23088706458 61 fields · synced May 17, 2026
- EUDAMED 9e53a9dd-0a35-438a-9aa9-e1c9d79e759b 61 fields · synced May 17, 2026
- EUDAMED 7799c756-31bb-4edb-9436-41d67bde1c97 61 fields · synced May 18, 2026
- EUDAMED 7fefb11c-cf26-410a-9c46-f3c6db3a5979 61 fields · synced May 18, 2026
- EUDAMED 742c0085-3853-46a9-bca7-98803c6fc032 61 fields · synced May 18, 2026
- EUDAMED 92806585-95c0-4712-ba33-7ffea073cb6e 61 fields · synced May 18, 2026
- EUDAMED 68005d72-7fe8-40b8-af9b-3f020b6424e4 61 fields · synced May 18, 2026
- EUDAMED a3d92859-1584-4579-9be0-3eff7dcd546a 61 fields · synced May 18, 2026
- EUDAMED 26a1523b-7851-4d0a-867e-2a4717cf1dea 61 fields · synced May 18, 2026
- EUDAMED df48837f-72f5-49a9-9756-0bd8333b2341 61 fields · synced May 18, 2026
- EUDAMED b7b22429-32b8-4fa7-9763-a7300c5273ea 61 fields · synced May 18, 2026
- EUDAMED fc9f8e84-1902-4e24-ac13-e8e4953464a1 61 fields · synced May 19, 2026