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Osseo 100+ Instrument

by Integration Diagnostics / NSK Nordic

Ref E1214

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735009632PenguinRF Basic UDI-DI 07350096320272UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350096320272 UDI-DI Date30 Oct 2024ListedStatusListed 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 25 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  • Withdrawn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
Osseo 100+ Instrument EUDAMED
Osseo 100+ GUDID
Generic Name
Multimeter
Device Name
Penguin Instruments
Model / Ref / Catalog
E1214 EUDAMED
Osseo 100+ Instrument GUDID
Y1004176 GUDID
Primary DI / UDI-DI
07350096320272
Basic UDI-DI
735009632PenguinRF
Direct Marketing DI
07350096320272
510(k) Number
FDA Product Code
EKX
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Multimeter
Device Class
Class I
Regulation Number
872.4200
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
E1214
GUDID
Osseo 100+ Instrument

Manufacturer details

EUDAMED SRN
SE-MF-000018550

Other devices from Integration Diagnostics / NSK Nordic

See all devices from Integration Diagnostics / NSK Nordic →

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