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Etiometry Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000016726 FEI 3011683100

Devices
13
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI

Catalogue13

Newest first, rows 1-13 of 13

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  • T3 Platform Software 2

    None Registry: GUDID Class:II

  • Etiometry Platform 2

    None Registry: GUDID Class:II

  • Etiometry Platform Ref K254066

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Software Ref K163065

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Software Ref K151715

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Platform software Ref K190273

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Platform software Ref K223578

    Expiring Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II

  • T3 Software Ref K152258

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Platform software Ref K213423

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Platform software Ref K202306

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Software Ref K142732

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T3 Platform Software Ref K213230

    Active Regimes: CE MDR 510(k) Registry: 510(k) Class:II

  • Etiometry Platform (DAV 5.4 RAE 9.2) Ref K241479

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-13 of 13

Company details

EUDAMED SRN
US-MF-000016726
FDA FEI number
3011683100
EUDAMED status
Active
EUDAMED registered name
Etiometry Inc.
Registered address
770, Legacy Place, 02026, Dedham, United States
Phone
+1 857 366 9333
PRRC contact
Tim Hanson(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 28 Feb 2027

EUDAMED certificates (1)

Intertek Medical Notified Body AB 2862 1 certificate

  • 28620127686-03 Expiring Expires in 122 days

    Quality management system EU MDR

    Issued
    3 Feb 2026
    Expires
    28 Feb 2027

Frequently asked questions

How many devices does ETIOMETRY INC. have in the registry?

The registry currently lists 13 devices for ETIOMETRY INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ETIOMETRY INC.'s devices?

Among its 13 most recently registered devices, ETIOMETRY INC. has devices listed in EUDAMED (1 device), FDA 510(k) (11 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.

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

Among its 13 most recently registered devices, the classes recorded for ETIOMETRY INC.'s devices are Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for ETIOMETRY INC.?

EUDAMED lists 1 certificate for ETIOMETRY INC. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-02-03.

What are the newest devices from ETIOMETRY INC. in the registry?

The most recently registered devices listed for ETIOMETRY INC. include T3 PLATFORM SOFTWARE 2, ETIOMETRY PLATFORM 2, Etiometry Platform and T3 Software.

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