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Delsys, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000037372

Delsys, Inc. is a medical device manufacturer based in the United States, with 43 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class I) as of 13 Nov 2026.

Devices
43
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 40
  • FDA 510(k) 3
  • EUDAMED 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 42
  • EU Class I 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000037372
  • DUNS 826428344

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
Authorised rep.
CS Life Sciences Europe LtdIE

What Delsys, Inc. makes

DELSYS, Inc. manufactures biofeedback and psychophysiological biofeedback systems, including EMG (electromyography) sensors, signal adapters, and data acquisition hardware. Products like the Trigno Avanti Sensor and Bagnoli-8 EMG System are designed for muscle activity monitoring, while adapters (e.g., load cell, analog input, and goniometer) enable integration with external devices for expanded functionality.

The company’s devices are classified as Class I or Class II under regulatory frameworks, with listings in eudamed, FDA’s 510(k) premarket notification database, and FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue43

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Rows 1-43 of 43

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000037372
DUNS number
826428344
EUDAMED status
Active
EUDAMED registered name
Delsys Inc.
Registered address
23, Strathmore Road, 01760, Natick, Massachusetts, United States
Website
delsys.com/
Phone
+1 (508) 545-8202
PRRC contact
Gianluca De Luca(public in EUDAMED)

Frequently asked questions

How many devices does DELSYS, INC. have in the registry?

The registry currently lists 43 devices for DELSYS, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list DELSYS, INC.'s devices?

Among its 43 most recently registered devices, DELSYS, INC. has devices listed in EUDAMED (1 device), FDA 510(k) (3 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do DELSYS, INC.'s devices fall under?

Among its 43 most recently registered devices, the classes recorded for DELSYS, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from DELSYS, INC. in the registry?

The most recently registered devices listed for DELSYS, INC. include Trigno Load Cell Adapter SP-W01G, Trigno Analog Input Adapter SP-W01K, Trigno Avanti Sensor SP-W06-014 and Trigno Galileo Sensor SP-W06-017.

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