Data / Medical devices / Singapore / Tilco Trading Pte. Ltd

Tilco Trading Pte. Ltd: FDA-registered device maker in Singapore Central Singapore, Singapore, 2 510(k) clearances

Name: Tilco Trading Pte. Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tilco Trading Pte. Ltd is registered with the FDA (registration 3015474594) in Singapore Central Singapore, Singapore. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 25, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015474594
Address: 16 Raffles Quay #33-03 Hong Leong Building, Singapore Central Singapore, Singapore, 048581
Owner or operator: TILCO TRADING PTE. LTD (10060394)
Roles: Exporter to the US
First device listed: May 7, 2019
Registered through: 2026
Brand names listed: Baby Milk Warmer with container, Curette, DERMA ROLLER; DERMA AUTO PEN; BEARD ROLLER, Ear Irrigation Kit, Hand Tester Kit, Headache Hat, Insulin syringe, Lung Muscle Exerciser and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Holder, Syringe	IQG	1	Exporter to the US	accessdata.fda.gov
Components, Exercise	IOD	1	Exporter to the US	accessdata.fda.gov
Curette, Adenoid	KBJ	1	Exporter to the US	accessdata.fda.gov
Device, Pressure Applying	KNM	1	Exporter to the US	accessdata.fda.gov
Douche Apparatus, Vaginal, Therapeutic	HED	1	Exporter to the US	accessdata.fda.gov
Ear Irrigation Kit	OGQ	1	Exporter to the US	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Exporter to the US	accessdata.fda.gov
Irrigator, Powered Nasal	KMA	1	Exporter to the US	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Exporter to the US	accessdata.fda.gov
Pill Crusher/Cutter	OHY	1	Exporter to the US	accessdata.fda.gov
Ring, Teething, Non-Fluid Filled	MEF	1	Exporter to the US	accessdata.fda.gov
Syringe, Antistick	MEG	2	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Exporter to the US	accessdata.fda.gov
Urinal	FNP	1	Exporter to the US	accessdata.fda.gov
Warmer, Irrigation Solution	LHC	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 25, 2016	K152808	U&U Insulin Syringe with/without Safety Retractable Device	MEG	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov
February 27, 2014	K132553	U&U STERILE PISTON SYRINGE WITHOUT NEEDLE	FMF	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 25, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.