Seca: FDA-registered device maker in Hamburg, Germany, 2 510(k) clearances

Name: Seca FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Seca is registered with the FDA (registration 3003587684) in Hamburg, Germany. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 23, 2020. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003587684
Address: Hammer Steindamm 3-25, Hamburg, Germany, 22089
Owner or operator: SECA (8010918)
Roles: Manufacturer
First device listed: February 3, 2005
Registered through: 2027
Brand names listed: 4900017, seca, seca 213, seca 452, seca analytics 115, seca analytics 125, seca connect 103, seca emr flash 101 and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition	MNW	2	Manufacturer	accessdata.fda.gov
Analyzer, Body Composition, Exempt	PUH	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
NSX	NSX		Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Scale, Patient	FRW	1	Manufacturer	accessdata.fda.gov
Scale, Platform, Wheelchair	INF	1	Manufacturer	accessdata.fda.gov
Scale, Stand-On, Patient	FRI	1	Manufacturer	accessdata.fda.gov
Scale, Surgical Sponge	FQA	1	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 23, 2020	K192092	Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535	DXN	Substantially Equivalent	Seca GmbH & Co. KG	accessdata.fda.gov
May 2, 2013	K122388	SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514	MNW	Substantially Equivalent	Seca GmbH & Co. KG	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 19, 2019	84817	Class II	Ongoing	Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009	It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become unstable and tip over, potentially leading to the scale falling from the cart. If a baby is left unattended in a cart, the baby could fall off the scale and be subjected to several se	accessdata.fda.gov

Compare with other makers

Updated January 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.