DS PrimeTaper 68015352: CE/MDR Class IIa

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number739253200235D8 Basic UDI-DI 07392532268465UDI-DI	Date6 Nov 2026Registered	StatusActive
United States	GUDID listing GUDID	Number07392532268465 UDI-DI	Date7 Jul 2022Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 739253200235D8 — open Devices and search for it
AccessGUDID record UDI-DI 07392532268465

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 739253200235D8 registered 6 Nov 2026 Active
FDA GUDID UDI-DI 07392532268465 listed 7 Jul 2022 Listed

Timeline

2 dated events

7 Jul 2022 Listed FDA GUDID 07392532268465
6 Nov 2026 Registered EUDAMED 739253200235D8

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: PrimeTaper Direction Indicator EUDAMED
DS PrimeTaper GUDID
Generic name: Dental implantation depth/angle gauge, reusable
Device name: PrimeTaper Surgical Supporting Instruments IIa Gauges
Model / Ref / Catalog: 68015352

Primary DI / UDI-DI: 07392532268465
Basic UDI-DI: 739253200235D8
FDA product code: NDP
EMDN code: P01020180 Dental implants - accessories
GMDN term: Dental implantation depth/angle gauge, 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

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class I
Sterilise before use	EUDAMED 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 07392532268465: EUDAMED states Yes, FDA GUDID states No.

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.