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Surflo Winged Infusion Set with Needle Protection (Surshield)

by Terumo Europe N.V.

Ref SV-S25BL35C

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05413206249541 UDI-DI Date4 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5413206SVSBLX3 Basic UDI-DI 05413206249541UDI-DIDate25 Jun 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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-S25BL35C
Primary DI / UDI-DI
05413206249541
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
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 25 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
BE-MF-000001434

Other devices from Terumo Europe N.V.

See all devices from Terumo Europe N.V. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No