Skip to content

Trackable Suction

by Synaptive Medical Inc.

Part of a family of 17 devices: see the family page

Ref SYN-0657

Trackable Suction (SYN-0657) is a device classified as Class IIa in the EU and Class II in the US made by Synaptive Medical Inc, registered in EUDAMED on 11 Apr 2025 (Basic UDI-DI 67008200003LM) and listed in FDA GUDID since 28 Feb 2017 (UDI-DI 00670082000184), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number67008200003LM Basic UDI-DI 00670082000184UDI-DIDate11 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00670082000184 UDI-DI Date28 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 67008200003LM registered 11 Apr 2025 Active
  • FDA GUDID UDI-DI 00670082000184 listed 28 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00670082000184
  2. Registered EUDAMED 67008200003LM

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  • Withdrawn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
Trackable Suction EUDAMED
Synaptive Trackable Suction - Standard Suction Set GUDID
Generic name
Suction cannula, reusable
Device name
Trackable Suction - Suction Set Standard
Model / reference
SYN-0657
Primary DI / UDI-DI
00670082000184
Basic UDI-DI
67008200003LM
FDA product code
GCX
EMDN code
L030101 Suction and irrigation surgical cannulas and handpieces, reusable
GMDN term
Suction cannula, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6740
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Manufacturer details

EUDAMED SRN
CA-MF-000010705
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Surgical/emergency suction cannula, non-illuminating, reusable

Similar devices in this category

Other devices filed under SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE.

Other devices from Synaptive Medical Inc

See all devices from Synaptive Medical Inc →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)