RFD Reference Detector 999-802-BT: EU MDR Class IIb

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number++EIBADIODESTA Basic UDI-DI EIBA999802BT0UDI-DI	Date17 Jul 2026Registered	StatusActive
United States	GUDID listing GUDID	NumberEIBA999802BT0 UDI-DI	Date9 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI ++EIBADIODESTA — open Devices and search for it

Across registries

2 registries list this device

EUDAMED Basic UDI-DI ++EIBADIODESTA registered 17 Jul 2026 Active
FDA GUDID UDI-DI EIBA999802BT0 listed 9 Sep 2016 Listed

Timeline

2 dated events

9 Sep 2016 Listed FDA GUDID EIBA999802BT0
17 Jul 2026 Registered EUDAMED ++EIBADIODESTA

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: RFD Reference Detector
Generic name: Radiation electrometer
Device name: Diode Detectors
Model / reference: 999-802-BT
Description: RFD 3G-pSi Reference Detector, BNC

Primary DI / UDI-DI: EIBA999802BT0
Basic UDI-DI: ++EIBADIODESTA
Direct marketing DI: EIBA999802BT0
FDA product code: IYE
EMDN code: Z119002 Dosimeters
GMDN term: Radiation electrometer

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 892.5050
EU registration type: Standard device
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIb	GUDID Class II

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