← Back to catalogue
Accufuser ABx
EUDAMEDClass IIb (EU MDR)
Ref AB1500LRef AB1000LRef AB0500SRef AB2000SRef AB2000MRef AB2500LRef AB2000XL
Identity
- Device Name
- Accufuser ABx EUDAMEDAccufuser ABx EUDAMED
- Model / Reference
- AB1500L EUDAMEDAB1000L EUDAMEDAB0500S EUDAMEDAB2000S EUDAMEDAB2000M EUDAMEDAB2500L EUDAMEDAB2000XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AB1500LC8 EUDAMEDD-AB1000LB5 EUDAMEDD-AB0500SCB EUDAMEDD-AB2000SBW EUDAMEDD-AB2000MBJ EUDAMEDD-AB2500LCK EUDAMEDD-AB2000XLS4 EUDAMED
- Basic UDI-DI
- B-AB1500LC8 EUDAMEDB-AB1000LB5 EUDAMEDB-AB0500SCB EUDAMEDB-AB2000SBW EUDAMEDB-AB2000MBJ EUDAMEDB-AB2500LCK EUDAMEDB-AB2000XLS4 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
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 ABx 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-AB1500LC8 | 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 (7)
- EUDAMED 9fc3075c-5752-49c4-9e1b-62e80da7d33b 61 fields · synced Jul 29, 2026
- EUDAMED 9d2327e8-753c-4bc5-b2c6-d9ded96244e9 61 fields · synced May 17, 2026
- EUDAMED b3d2aa8e-8b88-4373-8691-40f4554b331a 61 fields · synced May 17, 2026
- EUDAMED a36035d4-62bd-45e3-98f9-ad84d4ef6cc3 61 fields · synced May 17, 2026
- EUDAMED a638038b-d794-49d1-b2f6-e41a464b31e4 61 fields · synced May 17, 2026
- EUDAMED 6815eb53-84eb-4ab1-800c-2746dd87c1ff 61 fields · synced May 18, 2026
- EUDAMED ef7687b8-93f6-4907-9dc0-e1a8bb744ad9 61 fields · synced May 18, 2026