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ONENESS BIOTECH CO., LTD.

Taiwan · Taipei City · www.onenessbio.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN TW-MF-000032480

This company has registrations in European Union, United States, United Kingdom, Canada, Australia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

5UDI-DI device records

Class IIb 5

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 0Class III 0unclassified 1

plus 4 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIb 1

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

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.

European Union5 raw hits, 0 excluded, 5 confirmed

United States4 registration records, 2 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Manufacturer names merged into this page: Oneness Biotech Co., Ltd. · ONENESS BIOTECH CO., LTD.

Regulatory identity

EU manufacturer SRN: TW-MF-000032480
EU authorised representative: MedEnvoy Global BV
UK responsible person: MedEnvoy UK Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719883980199	Bonvadis®	Class IIb
EU	04719883980182	Bonvadis®	Class IIb
EU	04719883980175	Bonvadis®	Class IIb
EU	04719883980205	Bonvadis	Class IIb
UK	58133	Bonvadis Topical Cream	Class IIb
US	K261638	Bonvadis®	2026-06-17
US	K251093	Bonvadis®	2025-06-09

ONENESS BIOTECH CO., LTD.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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