Flattening Lance FL20: CE/MDR Class IIa

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number880972899163Q9 Basic UDI-DI 08806388244270UDI-DI	Date1 Sep 2026Registered	StatusActive
United States	GUDID listing GUDID	Number08806388244270 UDI-DI	Date7 Jul 2023Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 880972899163Q9 — open Devices and search for it
AccessGUDID record UDI-DI 08806388244270

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 880972899163Q9 registered 1 Sep 2026 Active
FDA GUDID UDI-DI 08806388244270 listed 7 Jul 2023 Listed

Timeline

2 dated events

7 Jul 2023 Listed FDA GUDID 08806388244270
1 Sep 2026 Registered EUDAMED 880972899163Q9

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: Flattening Lance
Generic name: Fixture/appliance dental drill bit, reusable
Model / Ref / Catalog: FL20

Primary DI / UDI-DI: 08806388244270
Basic UDI-DI: 880972899163Q9
FDA product code: NDP
EMDN code: L159099 Odontostomatology instruments, reusable - other
GMDN term: Fixture/appliance dental drill bit, reusable

Device class: Class IIa EUDAMED
Class I GUDID
Regulation number: 872.3980
EU registration type: Standard device
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.