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Surflo SV*S25BLSE

by Terumo Medical Products (Hangzhou) Co., Ltd.

Part of a family of 23 devices: see the family page

Ref SV*S25BLSE

Surflo SV*S25BLSE is a device classified as Class IIa in the EU and Class II in the US made by Terumo Medical Products (Hangzhou) Co., Ltd., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 69276755SVSAM) and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 06927675506849), active as of 25 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69276755SVSAM Basic UDI-DI 06927675506849UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06927675506849 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69276755SVSAM registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 06927675506849 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06927675506849
  2. Registered EUDAMED 69276755SVSAM

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  • Withdrawn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 EUDAMED
Surflo GUDID
Generic name
Basic intravenous administration set, invasive
Model / Ref / Catalog
SV*S25BLSE
Primary DI / UDI-DI
06927675506849
Basic UDI-DI
69276755SVSAM
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
Length — 0.75 Inch
Total Volume — 0.19 Milliliter
Needle Gauge — 25 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

Similar devices in this category

Other devices filed under BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS.

Other devices from Terumo Medical Products (Hangzhou) Co., Ltd.

See all devices from Terumo Medical Products (Hangzhou) Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)