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Darco International Trading (Shanghai) Ltd

✓ Record-verifiedregistrations found in 7 marketsEU SRN US-MF-000016195Unified social credit code 91310115703002635X

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia — 7 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. No China NMPA registrations were found.

Registrations by market

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

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 300

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

USUnited StatesFDA openFDA

15listed device types

Class I 15Class II 0Class III 0

plus 15 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 8

BRBrazilANVISA

4registered devices

Class I 4

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

SASaudi ArabiaSFDA

18registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 5

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 Union403 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States15 registration records, 2 510(k), 0 PMA, 3 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom8 confirmed, 2 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia18 confirmed, 0 excluded

Manufacturer names merged into this page: DARCO INTERNATIONAL, INC. · DARCO International · Darco International Inc. · .DARCO International Inc · Darco International Inc. · DARCO International , Inc.

Regulatory identity

EU manufacturer SRN: US-MF-000016195
EU authorised representative: Darco (Europe) GmbH
UK responsible person: DARCO UK Ltd
Unified social credit code: 91310115703002635X
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1999-03-25
Registered capital: USD 200,000
Paid-in capital: USD 200,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Telecommunications, broadcasting and satellite transmission
Last approval date: 2025-02-17
Recognitions: Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

22006 · K062103

FDA listed device types

showing 8 of 15

Orthosis, Corrective Shoe 1Protector, Skin Pressure 1Joint, Knee, External Brace 1Splint, Extremity, Inflatable, External 1Binder, Abdominal 1Splint, Clavicle 1Shoe, Cast 1Sling, Arm 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00609271120440	POGO® Pulsus	Class I
EU	00609271120778	POGO® Pulsus	Class I
EU	00609271120266	POGO® Pulsus	Class I
EU	00609271120600	POGO® Pulsus	Class I
UK	36206	AirTraveler Walker High	Class I
UK	10667	Body Armor® Cast Shoe	Class I
UK	65660	Toe Alignment Splint	Class I
US	K062103	DARCO FORCE TITANIUM COMPRESSION SCREW	2006-10-25
US	K061808	DARCO LOCKING BONE PLATE SYSTEM	2006-08-17
BR	81201010003	Palmilha ortopedica orthop	Class I
BR	81201010004	Sandália Ortopédica Orthop	Class I
BR	81201010006	Body armor toe guard	Class I
SA	ME0000006031SFDAA00003	CAST BOOT, CANVAS	—
SA	ME0000006031SFDAA00008	Ortho Wedge Shoe	—

Darco International Trading (Shanghai) Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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