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N1

by Osstem Implant Co., Ltd

Ref N1

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232012↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800000995809 UDI-DI Date27 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberB-08800000995809 Basic UDI-DI 08800000995809UDI-DIDate27 Dec 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08800000995809 Basic UDI-DI 08800000995809UDI-DIDate27 Dec 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK232012 Date28 Nov 2023IssuedStatusActive

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  • Withdrawn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, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Hand-held intraoral dental x-ray system, digital
Device Name
Portable X-ray System
Model / Reference
N1
Primary DI / UDI-DI
08800000995809
Basic UDI-DI
B-08800000995809, 8800406N1SC
510(k) Number
FDA Product Code
EHD
EMDN Code
Z1103040102 Equipment for digital endoral radiology
GMDN Term
Hand-held intraoral dental x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.1800
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000021655
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Dental digital imaging sensor, intraoral

Other devices from Osstem Implant Co., Ltd

See all devices from Osstem Implant Co., Ltd →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No