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Amplifon S.p.A.

Active in EUDAMED

Italyfrom SRN EUDAMED SRN IT-MF-000012109

Devices
12
Registrations
EUDAMED

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

Catalogue12

Newest first, rows 1-12 of 12

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  • OtoKiosk Ref OTK001

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Amplifon App Ref AMP-APP-001

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Amplaid A315 And A319 Ref K983915

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

  • Amplaid MK22 Ref K972959

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

  • Amplaid A311 Series Ref K983712

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

  • Amplaid 171S Ref K972862

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

  • Amplaid A724 And A728 Ref K992370

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

  • Amplaid AM50 Ref K974235

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

  • Amplaid 460 Ref K971747

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

  • Amplaid MK12 Ref K971740

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

  • OtoPad Ref OTP001

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • OtoRemote Ref OTR001

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Rows 1-12 of 12

Company details

EUDAMED SRN
IT-MF-000012109
EU VAT number
04923960159
EUDAMED status
Active
EUDAMED registered name
Amplifon S.p.A
Registered address
133, Via Ripamonti, 20141, Milan, Italy
Phone
08000372080(from company website)
PRRC contact
Simone Mezzavilla(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 20 Apr 2031

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 726263 Active Supplemented

    Quality management system EU MDR

    Issued
    24 Aug 2026
    Expires
    20 Apr 2031
    Reason
    Add device or group

From the company website

Read 18 Sep 2026

Book a free appointment in one of our 280+ hearing clinics. Free hearing tests and high-quality hearing aids.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Amplifon S.p.A have in the registry?

The registry currently lists 12 devices for Amplifon S.p.A. Devices recorded under merged duplicate company entries are counted once.

Which registries list Amplifon S.p.A's devices?

Among its 12 most recently registered devices, Amplifon S.p.A has devices listed in EUDAMED (4 devices), FDA 510(k) (8 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Amplifon S.p.A's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Amplifon S.p.A's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Amplifon S.p.A?

EUDAMED lists 1 certificate for Amplifon S.p.A (quality management system) under MDR. The most recent was issued on 24 Aug 2026.

What are the newest devices from Amplifon S.p.A in the registry?

The most recently registered devices listed for Amplifon S.p.A include OtoKiosk, Amplifon App, AMPLAID A315 AND A319 and AMPLAID MK22.

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