# Osstell AB

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/osstell-ab>
- Country: Sweden (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: SE-MF-000002162
- FDA FEI: 3004070020
- DUNS: 633171269

## Figures

- Devices: 158
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 152, EUDAMED 147, FDA 510(k) 4
- Device classes: EU Class I 140, FDA Class I 17, EU Class IIa 1
- EMDN [Q01 Dental devices](https://devicerts.com/categories/emdn/Q01): 141 devices

## Devices

The first 50 of 158, in the order of the canonical page, which lists them all.

- [Osstell SmartPeg Type 120](https://devicerts.com/devices/osstell-smartpeg-type-120-08086156) · Class I · EUDAMED, GUDID · status: Active
- [Osstell SmartPeg Type 121](https://devicerts.com/devices/osstell-smartpeg-type-121-08086157) · Class I · EUDAMED, GUDID · status: Active
- [Reusable SmartPeg](https://devicerts.com/devices/reusable-smartpeg-ekx) · ref K261987 · Class I · 510(k) · status: Active · decision 2026-09-08
- [SmartPeg Type 123](https://devicerts.com/devices/smartpeg-type-123-08086159) · ref 08086159 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 122](https://devicerts.com/devices/smartpeg-type-122-08086158) · ref 08086158 · Class I · EUDAMED, GUDID · status: Active
- [Osstell Instrument](https://devicerts.com/devices/osstell-instrument-103100) · ref 103100 · Class I · EUDAMED, GUDID · status: Active
- [Osstell Beacon](https://devicerts.com/devices/osstell-beacon-100668) · ref 100668 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 119](https://devicerts.com/devices/smartpeg-type-119-08086155) · ref 08086155 · Class I · EUDAMED, GUDID · status: Active
- [Osstell SmartPeg Type 41](https://devicerts.com/devices/osstell-smartpeg-type-41-100463) · Class I · GUDID · status: Listed
- [MEGA ISQ II Instrument Osstell MEGA ISQ II Instrument](https://devicerts.com/devices/mega-isq-ii-instrument-103100) · Class I · EUDAMED, GUDID · status: Active
- [Neoss SmartPeg Mount](https://devicerts.com/devices/neoss-smartpeg-mount-91075) · Class I · GUDID · status: Active
- [Osstell SmartPeg Type 42](https://devicerts.com/devices/osstell-smartpeg-type-42-100464) · Class I · GUDID · status: Listed
- [Osstell SmartPeg Type 64](https://devicerts.com/devices/osstell-smartpeg-type-64-100555) · Class I · GUDID · status: Listed
- [OsstellConnect Osstell OsstellConnect](https://devicerts.com/devices/osstellconnect-osstell-osstellconne) · Class I · GUDID · status: Listed
- [Osstell SmartPeg Type 70](https://devicerts.com/devices/osstell-smartpeg-type-70-100562) · Class I · GUDID · status: Listed
- [NeoTell](https://devicerts.com/devices/neotell-91060) · Class I · EUDAMED, GUDID · status: Active
- [Osstell Classic Instrument](https://devicerts.com/devices/osstell-classic-instrument-08086148) · Class I · EUDAMED, GUDID · status: Active
- [Osstell Beacon Instrument Osstell Osstell Beacon Instrument](https://devicerts.com/devices/osstell-beacon-instrument-103000) · Class I · EUDAMED, GUDID · status: Active
- [DIO IDx Instrument Osstell DIO IDx Instrument](https://devicerts.com/devices/dio-idx-instrument-100501) · Class I · GUDID · status: Active
- [SmartPeg Type 95](https://devicerts.com/devices/smartpeg-type-95-100758) · ref 100758 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 28](https://devicerts.com/devices/smartpeg-type-28-100432) · ref 100432 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 32](https://devicerts.com/devices/smartpeg-type-32-100440) · ref 100440 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 62](https://devicerts.com/devices/smartpeg-type-62-100545) · ref 100545 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 68](https://devicerts.com/devices/smartpeg-type-68-100560) · ref 100560 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 83](https://devicerts.com/devices/smartpeg-type-83-100714) · ref 100714 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 23](https://devicerts.com/devices/smartpeg-type-23-100411) · ref 100411 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 54](https://devicerts.com/devices/smartpeg-type-54-100485) · ref 100485 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 26](https://devicerts.com/devices/smartpeg-type-26-100425) · ref 100425 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 14](https://devicerts.com/devices/smartpeg-type-14-100374) · ref 100374 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 60](https://devicerts.com/devices/smartpeg-type-60-100543) · ref 100543 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 107 MegaGen](https://devicerts.com/devices/smartpeg-type-107-megagen-100744) · ref 100744 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 119R](https://devicerts.com/devices/smartpeg-type-119r-08086519) · ref 08086519 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 16](https://devicerts.com/devices/smartpeg-type-16-100388) · ref 100388 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 76](https://devicerts.com/devices/smartpeg-type-76-100582) · ref 100582 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 15](https://devicerts.com/devices/smartpeg-type-15-100386) · ref 100386 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 31](https://devicerts.com/devices/smartpeg-type-31-100438) · ref 100438 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 91](https://devicerts.com/devices/smartpeg-type-91-100750) · ref 100750 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 33](https://devicerts.com/devices/smartpeg-type-33-100442) · ref 100442 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 51](https://devicerts.com/devices/smartpeg-type-51-100482) · ref 100482 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 112](https://devicerts.com/devices/smartpeg-type-112-08086144) · ref 08086144 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 027R](https://devicerts.com/devices/smartpeg-type-027r-08086427) · ref 08086427 · Class I · EUDAMED, GUDID · status: Active
- [Osstell Isq Implant Stability Meter](https://devicerts.com/devices/osstell-isq-implant-stability-meter-ekx) · ref K082523 · Class I · 510(k) · status: Active · decision 2008-09-26
- [Mega Isq](https://devicerts.com/devices/mega-isq-ekx) · ref K132401 · Class I · 510(k) · status: Active · decision 2014-04-09
- [Osstell Beacon](https://devicerts.com/devices/osstell-beacon-ekx) · ref K181888 · Class I · 510(k) · status: Active · decision 2019-08-22
- [SmartPeg Type 96](https://devicerts.com/devices/smartpeg-type-96-100759) · ref 100759 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 053R](https://devicerts.com/devices/smartpeg-type-053r-08086453) · ref 08086453 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 01](https://devicerts.com/devices/smartpeg-type-01-100353) · ref 100353 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 99](https://devicerts.com/devices/smartpeg-type-99-100764) · ref 100764 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 49](https://devicerts.com/devices/smartpeg-type-49-100480) · ref 100480 · Class I · EUDAMED, GUDID · status: Active
- [SmartPeg Type 55](https://devicerts.com/devices/smartpeg-type-55-100487) · ref 100487 · Class I · EUDAMED, GUDID · status: Active

## Source and citation

- Cite as: Osstell AB. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/osstell-ab (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/osstell-ab.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/osstell-ab
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.