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Osstell Instrument

by Osstell AB

Ref 103100Model Osstell Beacon

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9010522Beacon1C5 Basic UDI-DI 09010522002674UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09010522002674 UDI-DI Date26 Sep 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
MEGA ISQ II Instrument
Generic Name
Dental implant stability resonance frequency analysis unit
Device Name
Osstell Instrument
Model / Ref / Catalog
Osstell Beacon, 103100, Osstell MEGA ISQ II Instrument
Primary DI / UDI-DI
09010522002674
Basic UDI-DI
9010522Beacon1C5
Direct Marketing DI
09010522002674
FDA Product Code
EKX
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Dental implant stability resonance frequency analysis unit
Device Class
Class I
Regulation Number
872.4200
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Osstell Beacon
103100
GUDID
Osstell MEGA ISQ II Instrument

Manufacturer details

EUDAMED SRN
SE-MF-000002162

Other devices from Osstell AB

See all devices from Osstell AB →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No