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Ultrafix Micromite

by Conmed Corporation

Part of a family of 12 devices: see the family page

Ref 10299, 10298

Ultrafix Micromite (10299) is a Class I device made by Conmed Corporation, registered in EUDAMED on 30 Apr 2026 (Basic UDI-DI 084585408435DB) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 10845854037164), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084585408435DB Basic UDI-DI Date30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854037164 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084585408435DB registered 30 Apr 2026 Active
  • FDA GUDID UDI-DI 10845854037164 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10845854037164
  2. Registered EUDAMED 084585408435DB

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  • Withdrawn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
Surgical drill guide, reusable
Orthopaedic implant driver
Device name
Orthopedic, Non-active, Reusable Surgical Instrument, Passing/Retrieval
Model / Ref / Catalog
10299, 10298
Primary DI / UDI-DI
10845854037164, 10845854037157
Basic UDI-DI
084585408435DB, B-10845854037157
Direct marketing DI
20845854037161
FDA product code
MDM, LXH
EMDN code
L091001, L0922
GMDN term
Surgical drill guide, reusable
Orthopaedic implant driver
Device class
Class I
Regulation number
878.4800, 888.4540
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Supplied sterileEUDAMED
No
Yes
GUDID
No
Sterilise before useEUDAMED
Yes
No
GUDID
Yes

Registry differences

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

  • Supplied sterile UDI-DI 10845854037157: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 10845854037157: EUDAMED states No, FDA GUDID states Yes.

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile NoEUDAMEDGUDIDYesEUDAMED
  • Sterilise before use YesEUDAMEDGUDIDNoEUDAMED
  • Reusable NoEUDAMEDYesEUDAMED
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)