BreathID Smart System VS07000W: EU IVDR Class B

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR EUDAMED	Number7290016923VS070008B Basic UDI-DI 07290016923346UDI-DI	Date27 Mar 2025Registered	StatusActive
United States	GUDID listing GUDID	Number07290016923346 UDI-DI	Date11 Apr 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) GUDID from GUDID	NumberK223185	Date10 Nov 2022Issued	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK220494	Date23 Jun 2022Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK193610	Date6 Feb 2020Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 7290016923VS070008B — open Devices and search for it
AccessGUDID record UDI-DI 07290016923346
FDA 510(k) database 510(k) number K223185
FDA 510(k) database 510(k) number K220494
FDA 510(k) database 510(k) number K193610

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 7290016923VS070008B registered 27 Mar 2025 Active
FDA 510(k) K223185 decided 10 Nov 2022 Active· +2 more in the status table
FDA GUDID UDI-DI 07290016923346 listed 11 Apr 2023 Listed

Timeline

5 dated events

6 Feb 2020 Cleared FDA 510(k) K193610
23 Jun 2022 Cleared FDA 510(k) K220494
10 Nov 2022 Cleared FDA 510(k) K223185
11 Apr 2023 Listed FDA GUDID 07290016923346
27 Mar 2025 Registered EUDAMED 7290016923VS070008B

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/IVDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: BreathID® Smart EUDAMED
BreathID Smart System GUDID
Generic name: Infrared spectrometry breath analyser IVD
Model / reference: VS07000W

Primary DI / UDI-DI: 07290016923346
Basic UDI-DI: 7290016923VS070008B
Direct marketing DI: 07290016923346
510(k) Number: K193610
K220494
K223185
FDA product code: MSQ, JJQ
EMDN code: W02069099 Various sample processing instruments - other
GMDN term: Infrared spectrometry breath analyser IVD

Device class: Class B EUDAMED
Class I GUDID
Regulation number: 866.3110, 862.2300
EU registration type: Standard device
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Size: Height — 16 Inch
Width — 15 Inch
Depth — 22 Inch
Weight — 15 Kilogram

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class B	GUDID Class I

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