seca GmbH & Co. KG

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Scale, Stand-On, Patient (FRI) (7) Analyzer, Body Composition, Exempt (PUH) (2) Scale, Patient (FRW) (1)

Premarket Exempt

No Yes

Clear

seca analytics 125 - 04012030020503 Catalog Number : 1252000010

Device Description : Cloud-based mBCA software for diagnosis and therapy support.

Device Class : 2

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

seca 787 - 04012030020671 Catalog Number : 7871821004

Device Description : The measuring station seca 787 measures and weighs in a single step. seca 787 is The measuring station seca 787 measures and weighs in a single step. seca 787 is equipped with an digital meauring rod.The scale has a maximum capacity of 250 kg / 550 lbs and a graduation of 100 g / 2 lbs. The measuring rod has a measuring range up to 230 cm / 90 inch and a graduation of 1 mm / 1/8 inch.Optional WLAN/LAN interface with seca 452.

Device Class : 1

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

seca 797 - 04012030020688 Catalog Number : 7971721004

Device Description : The measuring station seca 797 measures and weighs in a single step. seca 797 is The measuring station seca 797 measures and weighs in a single step. seca 797 is equipped with an digital meauring rod.The scale has a maximum capacity of 250 kg and a graduation of 100 g. The measuring rod has a measuring range up to 230 cm and a graduation of 1 mm.Integration capability through WLAN technology.

Device Class : 1

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

seca 797 - 04012030020695 Catalog Number : 7971821004

Device Description : The measuring station seca 797 measures and weighs in a single step. seca 797 is The measuring station seca 797 measures and weighs in a single step. seca 797 is equipped with an digital meauring rod.The scale has a maximum capacity of 250 kg / 550 lbs and a graduation of 100 g / 2 lbs. The measuring rod has a measuring range up to 230 cm / 90 inch and a graduation of 1 mm / 1/8 inch.Integration capability through WLAN technology

Device Class : 1

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

seca 787 - 04012030020701 Catalog Number : 7871721004

Device Description : The measuring station seca 787 measures and weighs in a single step. seca 787 is The measuring station seca 787 measures and weighs in a single step. seca 787 is equipped with an digital meauring rod.The scale has a maximum capacity of 250 kg and a graduation of 100 g. The measuring rod has a measuring range up to 230 cm and a graduation of 1 mm.Optional WLAN/LAN interface with seca 452.

Device Class : 1

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

seca 777 - 04012030020718 Catalog Number : 7771721004

Device Description : The measuring station seca 777 measures and weighs in a single step. seca 777 is The measuring station seca 777 measures and weighs in a single step. seca 777 is equipped with an analog meauring rod.The scale has a maximum capacity of 250 kg and a graduation of 100 g. The measuring rod has a measuring range up to 230 cm and a graduation of 1 mm.

Device Class : 1

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

seca 477 - 04012030020725 Catalog Number : 4770000009

Device Description : The seca 477 handrail serves as an accessory to the seca 777/787/797 column scal The seca 477 handrail serves as an accessory to the seca 777/787/797 column scales to allow patient stabilization on the scale platform during a weight measurement.

Device Class : 1

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

seca 777 - 04012030020732 Catalog Number : 7771821004

Device Description : The measuring station seca 777 measures and weighs in a single step. seca 777 is The measuring station seca 777 measures and weighs in a single step. seca 777 is equipped with an analog meauring rod.The scale has a maximum capacity of 250 kg / 550 lbs and a graduation of 100 g / 2 lbs.The measuring rod has a measuring range up to 230 cm / 90 inch and a graduation of 1 mm / 1/8 inch.

Device Class : 1

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

seca analytics 125 - 04012030020794 Catalog Number : 1252000012

Device Description : Cloud-based mBCA software for diagnosis and therapy support.

Device Class : 2

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

seca 333 - 04012030021050 Catalog Number : 3331021004

Device Description : EMR validated baby scale with WLAN function.

Device Class : 1

Duns Number: 316584937

Premarket Exempt : Yes

Product Code : FRW

Prescription Use : No

Device Count : 1

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