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PLUS EV HOLDINGS INC

USA · North Kansas City

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 6Class II 5Class III 0

plus 12 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States12 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: PLUS EV HOLDINGS INC

FDA 510(k) clearances by year

12020 · K193364

12023 · K231430

12024 · K241748

12026 · K250419

FDA listed device types

showing 8 of 11

Dilator, Vaginal 1Lubricant, Personal 1Perineometer 1Vibrator For Therapeutic Use, Genital 1Legging, Compression, Non-Inflatable 1Dilator, Rectal 1Paper, Obstetric Ph 1Applicator, Vaginal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250419	Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)	2026-07-27
US	K241748	Intimate Rose Vaginal Dilators	2024-08-14
US	K231430	Intimate Rose Vaginal Dilators	2023-06-07

PLUS EV HOLDINGS INC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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