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Seca GmbH & Co. KG

Germany · Hamburg

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

12listed device types

Class I 6Class II 5Class III 0unclassified 1

plus 12 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 3

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

IIa 3Class Im (measuring) 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 1Class 2a 5

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States12 registration records, 5 510(k), 0 PMA, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: SECA · SECA CORP. · SECA GMBH & CO. KG

FDA 510(k) clearances by year

31982 · K822135

12013 · K122388

12020 · K192092

FDA listed device types

showing 8 of 12

Stand, Infusion 1Scale, Platform, Wheelchair 1Scale, Stand-On, Patient 1Scale, Surgical Sponge 1Scale, Patient 1Medical Device Data System 1Analyzer, Body Composition, Exempt 1System, Measurement, Blood-Pressure, Non-Invasive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192092	Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535	2020-01-23
US	K122388	SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514	2013-05-02
US	K822135	SECA DIGITAL BABY SCALE 727	1982-07-30
CA	90107	MEDICAL BODY COMPOSITION ANALYZER (MBCA)	Class II
CA	96711	SECA 525- MEDICAL BODY COMPOSITION ANALYZER	Class II
CA	101530	SECA MVSA 535	Class II

Seca GmbH & Co. KG

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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