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seca 496

by seca GmbH & Co. KG

Ref 4960000009Model ACDIS001el

seca (4960000009) is an image display unit (EU MDR Class I; FDA Class I; FDA product code FRW, Scale, Patient) made by seca GmbH & Co. KG, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 401203000000000000066R3) and listed in FDA GUDID since 1 May 2024 (UDI-DI 04012030021494), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number401203000000000000066R3 Basic UDI-DI 04012030021494UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04012030021494 UDI-DI Date1 May 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 401203000000000000066R3 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 04012030021494 listed 1 May 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04012030021494
  2. Registered EUDAMED 401203000000000000066R3

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  • Withdrawn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
Image display unit, monochrome
Model / Ref / Catalog
ACDIS001el, 4960000009, 496
Primary DI / UDI-DI
04012030021494
Basic UDI-DI
401203000000000000066R3
Direct marketing DI
04012030021494
FDA product code
FRW
EMDN code
V0380 Devices with measuring functions - accessories
GMDN term
Image display unit, monochrome
Device class
Class I
Regulation number
880.2720
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ACDIS001el
4960000009
GUDID
496

Related devices

Category: Image display unit, monochrome

Similar devices

Also classified as Image display unit, monochrome.

Similar devices in this category

Other devices filed under DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES.

Other devices from seca GmbH & Co. KG

See all devices from seca GmbH & Co. KG →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)