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Osstell AB

Active in EUDAMED

Swedenfrom SRN EUDAMED FDA SRN SE-MF-000002162 FEI 3004070020

Osstell AB is a medical device manufacturer based in Sweden, with 158 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class I and IIa; FDA Class I) as of 15 Nov 2026.

Devices
158
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 152
  • EUDAMED 147
  • FDA 510(k) 4

A device listed in two registries counts in both.

Device classes
  • EU Class I 140
  • FDA Class I 17
  • EU Class IIa 1
Top EMDN categories
Identifiers
  • EUDAMED SRN SE-MF-000002162
  • FDA FEI 3004070020
  • DUNS 633171269

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Osstell AB makes

Osstell AB manufactures resonance frequency analysis units and associated pegs designed to measure dental implant stability. The company also produces dental treatment application software to support these diagnostic instruments.

The product portfolio is regulated under Class I and Class IIa classifications. These devices are listed in the EUDAMED, FDA 510(k), and FDA UDI databases, and the company is based in Sweden.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue158

Newest first, rows 1-50 of 158

Search and filter all 158 devices
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  • Osstell SmartPeg Type 120

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:I

  • Osstell SmartPeg Type 121

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:I

  • Reusable SmartPeg Ref K261987

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

  • SmartPeg Type 123 Ref 08086159

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 122 Ref 08086158

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Osstell Instrument Ref 103100

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Osstell Beacon Ref 100668

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 119 Ref 08086155

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Osstell SmartPeg Type 41

    Listed Registry: GUDID Class:I

  • MEGA ISQ II Instrument Osstell MEGA ISQ II Instrument

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Neoss SmartPeg Mount

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Osstell SmartPeg Type 42

    Listed Registry: GUDID Class:I

  • Osstell SmartPeg Type 64

    Listed Registry: GUDID Class:I

  • OsstellConnect Osstell OsstellConnect

    Listed Registry: GUDID Class:I

  • Osstell SmartPeg Type 70

    Listed Registry: GUDID Class:I

  • NeoTell

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:I

  • Osstell Classic Instrument

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:I

  • Osstell Beacon Instrument Osstell Osstell Beacon Instrument

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:I

  • DIO IDx Instrument Osstell DIO IDx Instrument

    Active Regimes: CE MDD Registry: GUDID Class:I

  • SmartPeg Type 95 Ref 100758

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 28 Ref 100432

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 32 Ref 100440

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 62 Ref 100545

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 68 Ref 100560

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 83 Ref 100714

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 23 Ref 100411

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 54 Ref 100485

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 26 Ref 100425

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 14 Ref 100374

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 60 Ref 100543

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 107 MegaGen Ref 100744

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 119R Ref 08086519

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 16 Ref 100388

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 76 Ref 100582

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 15 Ref 100386

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 31 Ref 100438

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 91 Ref 100750

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 33 Ref 100442

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 51 Ref 100482

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 112 Ref 08086144

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 027R Ref 08086427

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Osstell Isq Implant Stability Meter Ref K082523

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

  • Mega Isq Ref K132401

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

  • Osstell Beacon Ref K181888

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

  • SmartPeg Type 96 Ref 100759

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 053R Ref 08086453

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 01 Ref 100353

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 99 Ref 100764

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 49 Ref 100480

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SmartPeg Type 55 Ref 100487

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

Rows 1-50 of 158

Showing 1-50 of 158

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
SE-MF-000002162
FDA FEI number
3004070020
DUNS number
633171269
EU VAT number
SE556612493801
EUDAMED status
Active
EUDAMED registered name
Osstell AB
Registered address
14, Stampgatan, 411 01, Göteborg, Sweden
PRRC contact
Toyah Ohlson(public in EUDAMED)

Frequently asked questions

How many devices does Osstell AB have in the registry?

The registry currently lists 158 devices for Osstell AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list Osstell AB's devices?

Among its 50 most recently registered devices, Osstell AB has devices listed in EUDAMED (39 devices), FDA 510(k) (4 devices) and FDA GUDID (46 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Osstell AB's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Osstell AB's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Osstell AB in the registry?

The most recently registered devices listed for Osstell AB include Osstell SmartPeg Type 120, Osstell SmartPeg Type 121, Reusable SmartPeg and SmartPeg Type 123.

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