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Apex (Guangzhou) Tools & Orthopedics Co.

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000018403

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia, Israel — 8 overseas markets. EU UDI-DI records ≥3, 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

≥3UDI-DI device records

Class IIa 3

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

USUnited StatesFDA openFDA

62listed device types

Class I 41Class II 21Class III 0

plus 98 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 2Class IIa 6

BRBrazilANVISA

6registered devices

Class I 3Class II 3

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

2active device licences

Class II 2

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

IIa 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union536 raw hits, 297 excluded, 3 confirmed. Large result set — only the first 300 verified

United States98 registration records, 2 510(k), 0 PMA, 26 excluded

United Kingdom8 confirmed, 3 excluded

Brazil6 confirmed, 5 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: Apex (Guangzhou) Tools & Orthopedics Company · APEX (GUANGZHOU) TOOLS & ORTHOPEDICS CO.

Regulatory identity

EU manufacturer SRN: CN-MF-000018403
EU authorised representative: Wellkang Ltd
UK responsible person: Wellkang Ltd
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12011 · K112254

12012 · K121004

FDA listed device types

showing 8 of 62

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Rasp 1Impactor 1Punch, Surgical 1Guide, Surgical, Instrument 1Osteotome, Manual 1Screwdriver 1Driver, Surgical, Pin 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	16957277200101	iTool® ApexpulseTM	Class IIa
EU	16957277200088	iTool® ApexpulseTM	Class IIa
EU	16957277200095	iTool® ApexpulseTM	Class IIa
UK	11301	Disposable Irrigation Bags	Class I
UK	47890	Disposable Pulse Lavages	Class IIa
UK	47891	Disposable Lavage Tips	Class IIa
US	K121004	APEX KIRSCHNER WIRES AND STEINMANN PINS	2012-04-24
US	K112254	APEX KIRSCHNER WIRES AND STEINMANN PINS	2011-10-11
BR	82339070002	Pontas Pulsar II AWI	Class I
BR	80517199001	Lâmina expansível descartável EasyCore Hip	Class II
BR	80517190016	EasyCore Hip	Class I
CA	90169	DRILL BIT	Class II
CA	90296	APEXPULSE	Class II

Apex (Guangzhou) Tools & Orthopedics Co.

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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