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Terumo SS+30L1

by Terumo (Philippines) Corporation

Part of a family of 32 devices: see the family page

Ref SS+30L1

Terumo SS+30L1 is a device classified as Class IIa in the EU and Class II in the US made by Terumo (Philippines) Corporation, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 48060175SSB6), cleared under FDA 510(k) K063613 on 26 Dec 2006 and listed in FDA GUDID since 27 Jan 2017 (UDI-DI 14806017509436), 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) K063613

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 Number48060175SSB6 Basic UDI-DI 14806017509436UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14806017509436 UDI-DI Date27 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK063613 Date26 Dec 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 48060175SSB6 registered 9 Oct 2026 Active
  • FDA 510(k) K063613 decided 26 Dec 2006 Active
  • FDA GUDID UDI-DI 14806017509436 listed 27 Jan 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K063613
  2. Listed FDA GUDID 14806017509436
  3. Registered EUDAMED 48060175SSB6

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  • Withdrawn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
Terumo Syringe without Needle EUDAMED
Terumo GUDID
Generic name
Metered-delivery hypodermic syringe
Model / reference
SS+30L1
Primary DI / UDI-DI
14806017509436
Basic UDI-DI
48060175SSB6
510(k) Number
FDA product code
FMF
EMDN code
A020102020102 Infusion and irrigation syringes, luer lock cone, 3-piece without needle, single-use
GMDN term
Metered-delivery hypodermic syringe
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5860
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 30 Milliliter

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: Metered-delivery hypodermic syringe

Cleared under the same submission (K063613)

and 2 more cleared under K063613

Similar devices in this category

Other devices filed under INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE.

Other devices from Terumo (Philippines) Corporation

See all devices from Terumo (Philippines) Corporation →

Properties

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