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SHANGHAI LANGE MEDTECH CO., LTD.

China · Shanghai

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 3 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

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 15Class II 1Class III 0

plus 15 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 5

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

3valid device licences

Class I 1Class II 2

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 States15 registration records, 1 510(k), 0 PMA, 2 excluded

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: SHANGHAI LANGE MEDTECH CO., LTD. · SHANGHAI LANGE MEDTECH CO., LTD

FDA 510(k) clearances by year

12025 · K252458

FDA listed device types

showing 8 of 16

Instrument, Cutting, Orthopedic 1Dilator, Catheter 1Forceps 1Spatula, Surgical, General & Plastic Surgery 1Bone Marrow Biopsy Tray 1Head, Surgical, Hammer 1Spinal Channeling Instrument, Vertebroplasty 1Stripper, Vein, Reusable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252458	Kyphoplasty Balloon Dilatation Catheters	2025-11-03
BR	82193580001	Instrumentos Lange Aço inoxidavel-NiTi	Class I
BR	82193580002	Instrumentos Lange Aço inoxidavel-DLC	Class I
BR	82193580003	Instrumentos Lange Polimero-Aço inox	Class I

SHANGHAI LANGE MEDTECH CO., LTD.

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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