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MANI, INC.

Japan · Utsunomiya Tochigi · www.mani.co.jp/en/img/main.png

✓ Record-verifiedregistrations found in 12 marketsEU SRN JP-MF-000017860

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥84, the first 300 verified individually. 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

≥84UDI-DI device records

Class IIa 84

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

25registered device records

Class I 3Class IIa 16Class IIb 6

BRBrazilANVISA

12registered devices

Class I 6Class II 6

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

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

13 including historic records

TWTaiwanTFDA

6valid device licences

Class I 5Class II 1

SGSingaporeHSA SMDR

9device registrations

CLASS B 7CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 3IIa 9

HKHong KongMDACS

4valid listings

Class II 2Class III 1Class IV 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 1Class 2a 3Class 2b 2

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 Union6,363 raw hits, 16 excluded, 84 confirmed. Large result set — only the first 300 verified

United States0 registration records, 4 510(k), 0 PMA, 6 excluded

United Kingdom25 confirmed, 3 excluded

Brazil12 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: MANI, INC. · MANI INC. · MANI, INC · Mani Inc.

Regulatory identity

EU manufacturer SRN: JP-MF-000017860
EU authorised representative: Obelis s.a.
UK responsible person: Obelis UK Ltd

Business registration

Corporate Number: 4060001005922
Registration status: Active
Registered capital: JPY 1,059,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04546951534554	MANI CARBIDE BURS - 703	Class IIa
EU	04546951534370	MANI CARBIDE BURS - 2	Class IIa
EU	04546951601485	MANI CARBIDE BURS - 3(CA)	Class IIa
EU	04546951617011	MANI SURGICAL BURS - 30mm #1559L	Class IIa
UK	16668	Carbide dental bur, reusable	Class IIa
UK	16670	Diamond dental bur, reusable	Class IIa
UK	35784	MANI SHORT BARBED BROACHES	Class I
US	K053638	MANI NEEDLE & SUTURE PACK (SILK)	2006-05-19
US	K053637	MANI NEEDLE & SUTURE PACK (NYLON)	2006-05-19
US	K053636	MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)	2006-03-14
BR	10347940125	LIMAS ROTATÓRIAS SST MANI	Class I
BR	10347940146	Brocas Carbide Mani	Class I
BR	10347940057	BROCAS PARA CANAL MANI	Class I
SA	ME0000012084SFDAA00001	MANI REAMERS	—
SA	ME0000012084SFDAA00002	MANI SHORT BARBED BROACHES	—
CA	73465	MANI DIAMOND TOMITA-SAW	Class II
CA	89905	MANI NRT FILES	Class II

MANI, INC.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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