BC Medium Applicator VTL45930: CE/MDD Class IIb, Viora Ltd

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-07290016746419 Basic UDI-DI 07290016746419UDI-DI	Date24 Jun 2026Registered	StatusActive
United States	GUDID listing GUDID	Number07290016746419 UDI-DI	Date5 Jul 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK162363	Date18 Nov 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK152611	Date19 Feb 2016Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK150035	Date1 May 2015Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-07290016746419 — open Devices and search for it
AccessGUDID record UDI-DI 07290016746419
FDA 510(k) database 510(k) number K162363
FDA 510(k) database 510(k) number K152611
FDA 510(k) database 510(k) number K150035

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-07290016746419 registered 24 Jun 2026 Active
FDA 510(k) K162363 decided 18 Nov 2016 Active· +2 more in the status table
FDA GUDID UDI-DI 07290016746419 listed 5 Jul 2017 Listed

Timeline

5 dated events

1 May 2015 Cleared FDA 510(k) K150035
19 Feb 2016 Cleared FDA 510(k) K152611
18 Nov 2016 Cleared FDA 510(k) K162363
5 Jul 2017 Listed FDA GUDID 07290016746419
24 Jun 2026 Registered EUDAMED B-07290016746419

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

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

Specification

EUDAMED · GUDID

Trade name: BC Medium Applicator
Generic name: Multi-modality skin/body contouring system
Model / Ref / Catalog: VTL45930, BC Medium Applicator

Primary DI / UDI-DI: 07290016746419
Basic UDI-DI: B-07290016746419
510(k) Number: K150035
K152611
K162363
FDA product code: PBX, ISA
EMDN code: V9099 Various devices not included in other classes - other
GMDN term: Multi-modality skin/body contouring system

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 878.4400, 890.5660
System or procedure pack: System which is a device in itself
EU registration type: Legacy device (under a directive)
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.