Surflo™ Sv-S23FL35: CE/MDR Class IIa, Terumo Europe NV

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number5413206SVSFLXF Basic UDI-DI 05413206054923UDI-DI	Date1 Jul 2026Registered	StatusActive
United States	GUDID listing GUDID	Number05413206054923 UDI-DI	Date5 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK133894	Date18 Mar 2014Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 5413206SVSFLXF — open Devices and search for it
AccessGUDID record UDI-DI 05413206054923
FDA 510(k) database 510(k) number K133894

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 5413206SVSFLXF registered 1 Jul 2026 Active
FDA 510(k) K133894 decided 18 Mar 2014 Active
FDA GUDID UDI-DI 05413206054923 listed 5 Sep 2016 Listed

Recalls

1 recall · FDA

- Terminated Z-0551-2016 FDA Class II initiated 23 Nov 2015 on shared 510(k) K133894
Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

18 Mar 2014 Cleared FDA 510(k) K133894
23 Nov 2015 Recall initiated FDA recalls Z-0551-2016
5 Sep 2016 Listed FDA GUDID 05413206054923
1 Jul 2026 Registered EUDAMED 5413206SVSFLXF

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) EUDAMED
Surflo™ GUDID
Generic name: Basic intravenous administration set, invasive
Model / Ref / Catalog: SV-S23FL35

Primary DI / UDI-DI: 05413206054923
Basic UDI-DI: 5413206SVSFLXF
510(k) Number: K133894
FDA product code: FPA
EMDN code: A01010201 Butterfly needles, with safety systems
GMDN term: Basic intravenous administration set, invasive

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 880.5440
EU registration type: Standard device
EU market of registration: Belgium
GUDID distribution status: In Commercial Distribution

Size: Needle Gauge — 23 Gauge
Pore Size — 20 Micrometer

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.