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seca mBCA 550

by seca GmbH & Co. KG 2 variants

Ref 5500000009Model ACBCA001elmf

seca mBCA 550 (5500000009) is a device classified as Class IIa in the EU and Class II in the US made by seca GmbH & Co. KG, registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI 401203000000000000002Q9) and listed in FDA GUDID since 20 Mar 2020 (UDI-DI 04012030020138), 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 Number401203000000000000002Q9 Basic UDI-DI 04012030020138UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04012030020138 UDI-DI Date20 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 401203000000000000002Q9 registered 8 Oct 2026 Active
  • FDA GUDID UDI-DI 04012030020138 listed 20 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04012030020138
  2. Registered EUDAMED 401203000000000000002Q9

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  • Withdrawn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
Bioelectrical body composition analyser
Model / Ref / Catalog
ACBCA001elmf, 5500000009, 550
Primary DI / UDI-DI
04012030020138
Basic UDI-DI
401203000000000000002Q9
Direct marketing DI
04012030020138
FDA product code
PUH
EMDN code
Z12099001 Body impedance analysers
GMDN term
Bioelectrical body composition analyser
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2770
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ACBCA001elmf
5500000009
GUDID
550
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: Bioelectrical body composition analyser

Similar devices in this category

Other devices filed under BODY IMPEDANCE ANALYSERS.

Other devices from seca GmbH & Co. KG

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Properties

  • Measuring function
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)