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Modus Blue

by Synaptive Medical Inc.

Ref SYN-0988

Modus Blue (SYN-0988) is a general-purpose surgical microscope (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Synaptive Medical Inc, registered in EUDAMED on 11 Apr 2025 (Basic UDI-DI 67008200008LX) and listed in FDA GUDID since 6 Mar 2023 (UDI-DI 00670082000580), 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 Number67008200008LX Basic UDI-DI 00670082000580UDI-DIDate11 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00670082000580 UDI-DI Date6 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 67008200008LX registered 11 Apr 2025 Active
  • FDA GUDID UDI-DI 00670082000580 listed 6 Mar 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00670082000580
  2. Registered EUDAMED 67008200008LX

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  • Withdrawn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

Generic name
General-purpose surgical microscope
Model / reference
SYN-0988
Primary DI / UDI-DI
00670082000580
Basic UDI-DI
67008200008LX
FDA product code
EPT
EMDN code
Z12011199 Instruments for operative microscopy – other
GMDN term
General-purpose surgical microscope
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Manufacturer details

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

Similar devices in this category

Other devices filed under INSTRUMENTS FOR OPERATIVE MICROSCOPY – OTHER.

Other devices from Synaptive Medical Inc

See all devices from Synaptive Medical Inc →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)