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Medical Microscope

by Denjoy Dental Co., Ltd 3 variants

Ref iX6Model iX6,iX7,iX8

Medical Microscope (iX6) is a general-purpose surgical microscope (EU MDR Class I; FDA Class I; FDA product code FSO, Microscope, Surgical, General & Plastic Surgery) made by Denjoy Dental Co., Ltd, registered in EUDAMED on 7 May 2025 (Basic UDI-DI 6970873260167BH) and listed in FDA GUDID since 19 Feb 2022 (UDI-DI 06970873260167), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6970873260167BH Basic UDI-DI 06970873260167UDI-DIDate7 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06970873260167 UDI-DI Date19 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 6970873260167BH registered 7 May 2025 Active
  • FDA GUDID UDI-DI 06970873260167 listed 19 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06970873260167
  2. Registered EUDAMED 6970873260167BH

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  • Withdrawn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

Generic name
General-purpose surgical microscope
Model / reference
iX6, iX7, iX8
Primary DI / UDI-DI
06970873260167
Basic UDI-DI
6970873260167BH
Direct marketing DI
06970873260167
FDA product code
FSO
EMDN code
Z12011101 Operative microscopes
GMDN term
General-purpose surgical microscope
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 06970873260167: EUDAMED states Yes, FDA GUDID states No.

Manufacturer details

EUDAMED SRN
CN-MF-000044157
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Similar devices in this category

Other devices filed under OPERATIVE MICROSCOPES.

Other devices from Denjoy Dental Co., Ltd

See all devices from Denjoy Dental Co., Ltd →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)