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Timpel S/A

Active in EUDAMED

Brazilfrom SRN EUDAMED FDA SRN BR-MF-000015742 FEI 3013853674

Timpel S/A is a medical device manufacturer based in Brazil, with 129 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I and IIa) as of 15 Nov 2026.

Devices
129
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 105
  • EUDAMED 78
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 100
  • EU Class I 26
  • EU Class IIa 3
Identifiers
  • EUDAMED SRN BR-MF-000015742
  • FDA FEI 3013853674
  • DUNS 897939320

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Timpel S/A makes

Timpel S/A manufactures single-use and reusable thoracic electrical impedance electrode arrays, including adhesive-backed and conductive tape variants, as well as chest positioners for electrode placement. Their product line also includes tomographic electrical impedance systems and non-scalp cutaneous leads designed for analytical applications.

These devices are classified as Class II under regulatory frameworks, with submissions listed in the FDA’s 510(k) and UDI registries. The company operates within the United States, adhering to domestic medical device regulations.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue129

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
BR-MF-000015742
FDA FEI number
3013853674
DUNS number
897939320
EUDAMED status
Active
EUDAMED registered name
TIMPEL S.A.
Registered address
280, Rua José Leonardi, 85.503-000, Pato Branco, Brazil
Phone
+551130880305
PRRC contact
Taciana Trigo(public in EUDAMED)

Frequently asked questions

How many devices does Timpel S/A have in the registry?

The registry currently lists 129 devices for Timpel S/A. Devices recorded under merged duplicate company entries are counted once.

Which registries list Timpel S/A's devices?

Among its 50 most recently registered devices, Timpel S/A has devices listed in EUDAMED (49 devices) and FDA GUDID (29 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Timpel S/A's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Timpel S/A's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Timpel S/A in the registry?

The most recently registered devices listed for Timpel S/A include ENLIGHT Disposable Belt - Size N3, ENLIGHT Reference Cable, ENLIGHT Disposable Belt - Size N0 and Neonatal Cable.

Generated automatically from registry data and not verified by a human reviewer.