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Instrument ATEMH0119

by Howmedica Osteonics Corp.

Ref ATEMH0119Model 08858250000816SA

Instrument ATEMH0119 is a Class I device made by Howmedica Osteonics Corp., registered in EUDAMED on 30 Oct 2025 (Basic UDI-DI 08858250000816SA) and listed in FDA GUDID since 8 Jan 2024 (UDI-DI 07613327565850), 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 Number08858250000816SA Basic UDI-DI 07613327565850UDI-DIDate30 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327565850 UDI-DI Date8 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000816SA registered 30 Oct 2025 Active
  • FDA GUDID UDI-DI 07613327565850 listed 8 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327565850
  2. Registered EUDAMED 08858250000816SA

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  • Withdrawn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
Instrument
Generic name
Surgical implant template, reusable
Device name
TF-018 Class I (m) - Surgical Templates
Model / Ref / Catalog
ATEMH0119, 08858250000816SA
Primary DI / UDI-DI
07613327565850
Basic UDI-DI
08858250000816SA
Direct marketing DI
07613327565850
FDA product code
HWT
EMDN code
V030204 Implant measurement devices not included in other classes
GMDN term
Surgical implant template, reusable
Device class
Class I
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical implant template, reusable

Similar devices in this category

Other devices filed under IMPLANT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Reusable
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)