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MEDITEC TECHNOLOGY COMPANY LIMITED

Viet Nam · Bac Ninh B?C Ninh

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. 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

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 4Class II 4Class III 0

plus 10 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

TWTaiwanTFDA

pendingnot queried

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 States10 registration records, 7 510(k), 0 PMA, 27 excluded

Brazil0 confirmed, 11 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: Carl Zeiss Meditec Cataract Technology Inc · MEDITEC TECHNOLOGY COMPANY LIMITED

FDA 510(k) clearances by year

12019 · K191024

22020 · K200207

22022 · K214028

22025 · K243395

FDA listed device types

Syringe, Piston 1Unit, Phacofragmentation 1Catheter, Straight 1Vitrectomy, Instrument Cutter 1Container, Specimen, Non-Sterile 1Syringe, Irrigating (Non Dental) 1Container, Specimen, Sterile 1Hook, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243395	MICOR 700 with Auto I/A	2025-08-08
US	K242801	MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)	2025-06-11
US	K214028	MICOR Lens Fragmentation System	2022-09-09

MEDITEC TECHNOLOGY COMPANY LIMITED

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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