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seca 452

by seca GmbH & Co. KG 2 variants

Ref 4520000009Model ACIM001el

seca 452 (4520000009) is a Class I device made by seca GmbH & Co. KG, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 401203000000000000016QL) and listed in FDA GUDID since 18 Dec 2018 (UDI-DI 04012030019460), 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 Number401203000000000000016QL Basic UDI-DI 04012030019460UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04012030019460 UDI-DI Date18 Dec 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 401203000000000000016QL registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 04012030019460 listed 18 Dec 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04012030019460
  2. Registered EUDAMED 401203000000000000016QL

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  • Withdrawn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
Medical equipment clinical data interfacing software
Model / Ref / Catalog
ACIM001el, 4520000009, 452
Primary DI / UDI-DI
04012030019460
Basic UDI-DI
401203000000000000016QL
Direct marketing DI
04012030019460
FDA product code
OUG
EMDN code
V0380 Devices with measuring functions - accessories
GMDN term
Medical equipment clinical data interfacing software
Device class
Class I
Regulation number
880.6310
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ACIM001el
4520000009
GUDID
452

Related devices

Category: Medical equipment clinical data interfacing software

Similar devices in this category

Other devices filed under DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES.

Other devices from seca GmbH & Co. KG

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Properties

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