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Surflo™ Sv-S23BL35

by Terumo Europe NV

Ref SV-S23BL35

Surflo™ Sv-S23BL35 is a device classified as Class IIa in the EU and Class II in the US made by Terumo Europe NV, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI 5413206SVSBLX3), cleared under FDA 510(k) K133867 on 5 Feb 2014 and listed in FDA GUDID since 5 Sep 2016 (UDI-DI 05413206054886), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133867

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5413206SVSBLX3 Basic UDI-DI 05413206054886UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05413206054886 UDI-DI Date5 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK133867 Date5 Feb 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5413206SVSBLX3 registered 25 Jun 2026 Active
  • FDA 510(k) K133867 decided 5 Feb 2014 Active
  • FDA GUDID UDI-DI 05413206054886 listed 5 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133867
  2. Listed FDA GUDID 05413206054886
  3. Registered EUDAMED 5413206SVSBLX3

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • 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  • Withdrawn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 Needle Protection (Surshield) EUDAMED
Surflo™ GUDID
Generic name
Basic intravenous administration set, invasive
Model / Ref / Catalog
SV-S23BL35
Primary DI / UDI-DI
05413206054886
Basic UDI-DI
5413206SVSBLX3
510(k) Number
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
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.

Related devices

Category: Basic intravenous administration set, invasive

Cleared under the same submission (K133867)

Similar devices in this category

Other devices filed under BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS.

Other devices from Terumo Europe NV

See all devices from Terumo Europe NV →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)