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MagiCath II
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 2P24BRef 2P18BRef 2P16FRef 2P16ERef 2P20BRef 2P26ARef 2P20DRef 2P20CRef 2P18DRef 2P22BRef 2P18CRef 2P24A
Identity
- Device Name
- MagiCath II EUDAMED
- Model / Reference
- 2P24B EUDAMED2P18B EUDAMED2P16F EUDAMED2P16E EUDAMED2P20B EUDAMED2P26A EUDAMED2P20D EUDAMED2P20C EUDAMED2P18D EUDAMED2P22B EUDAMED2P18C EUDAMED2P24A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806368584778 EUDAMED08806368584839 EUDAMED08806368584884 EUDAMED08806368584877 EUDAMED08806368584808 EUDAMED08806368584860 EUDAMED08806368584822 EUDAMED08806368584815 EUDAMED08806368584853 EUDAMED08806368584785 EUDAMED08806368584846 EUDAMED08806368584761 EUDAMED
- Basic UDI-DI
- B-08806368584778 EUDAMEDB-08806368584839 EUDAMEDB-08806368584884 EUDAMEDB-08806368584877 EUDAMEDB-08806368584808 EUDAMEDB-08806368584860 EUDAMEDB-08806368584822 EUDAMEDB-08806368584815 EUDAMEDB-08806368584853 EUDAMEDB-08806368584785 EUDAMEDB-08806368584846 EUDAMEDB-08806368584761 EUDAMED
- EMDN Code
- C0101010202 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, W/O INJECTION VALVES EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MagiCath II by Woo Young Medical Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210929 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08806368584778 | Class IIa | 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 (13)
- EUDAMED 73532d4a-755f-489c-bb7b-7b6829437609 61 fields · synced Oct 6, 2026
- EUDAMED be260a4e-acac-49b5-82ab-5e2c078e5275 61 fields · synced May 16, 2026
- EUDAMED bb8abd0e-907b-4a48-8c78-898cd0ed6cec 61 fields · synced May 16, 2026
- EUDAMED 48c94849-366b-413b-8334-f9c674e3a55e 61 fields · synced May 16, 2026
- EUDAMED 44e1e1f1-f870-400e-b61b-2c5fb6c87e84 61 fields · synced May 16, 2026
- EUDAMED 3fa50e59-66cc-40f4-9b0c-a18d875d5afb 61 fields · synced May 17, 2026
- EUDAMED 2654ecaa-78c9-4e01-bbb6-e7c4507164e4 61 fields · synced May 17, 2026
- EUDAMED f01f02b9-7704-4a15-ad26-6a402d2a135a 61 fields · synced May 17, 2026
- EUDAMED a838cdca-8db9-406e-ab71-e457e61fedf0 61 fields · synced May 18, 2026
- EUDAMED 088180e8-82a6-4d4a-a998-074b3fb57b86 61 fields · synced May 18, 2026
- EUDAMED 6fd51f2a-56c1-47ff-a042-4c65f0a4a852 61 fields · synced May 18, 2026
- EUDAMED 1f12ea59-9bfa-4aec-9289-20ea81d12a71 61 fields · synced May 18, 2026
- FDA 510(k) K210929 1 fields · synced May 18, 2026