Delbio Inc

FDA Filings

This page includes the latest FDA filings for Delbio Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3009020773
FEI Number	3009020773
Name	DELBIO INCORPORATION
Owner & Operator	DELBio INC.
Contact Address	3F, No.252, Shangying Road, Guishan Industrial Zone Taoyuan TW-NOTA 33341 TW
Official Correspondent	Herbert Ho 886-3-3596268-8600
US Agent	TiSeng Lin Delta Products Corporation 510 6685139 Safety@deltaww.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	3, 7F., No. 252, SHANGYING RD. GUISHAN DIST. TAOYUAN CITY, 333 TW
Establishment Type	Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device

Registration Number

3010804448

FEI Number

3010804448

Name

TISENG LIN

Owner & Operator

DELBio INC.

Contact Address

3F, No.252, Shangying Road, Guishan Industrial Zone
Taoyuan TW-NOTA 33341 TW

Official Correspondent

Herbert Ho
886-3-3596268-8600

US Agent

TISENG LIN
DELTA PRODUCTS CORPORATION
510 6685139
Safety@deltaww.com

Importing Logistics Registration

Importer	Turner Medical, Inc
Address	74 Chestnut St. Willimantic, CT 06226 Willimantic, CT 06226 UNITED STATES

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

5101 DAVIS DR
Research Triangle Park, NC 27709 US

Establishment Type

Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 04713072981554 DELBIO INC.	Turner	2023-12-04
GUDID 04713072981547 DELBIO INC.	Turner	2023-12-04
GUDID 04713072980786 DELBIO INC.	O2Health fingertip pulse oximeter	2020-04-24
GUDID 04713072980748 DELBIO INC.	O2Health fingertip pulse oximeter	2020-04-24
PMN K133892 \| HLI TISENG LIN [DELBio INC.]	ophthalmoscope	2018-04-27
PMN K133892 \| HLI DELBIO INCORPORATION [DELBio INC.]	ophthalmoscope	2018-04-27
PMN K133090 \| DQA TISENG LIN [DELBio INC.]	Oximeter	2016-11-28
PMN K133090 \| DQA TISENG LIN [DELBio INC.]	O2Health fingertip pulse oximeter, Model: DB12	2016-11-28
PMN K133090 \| DQA DELBIO INCORPORATION [DELBio INC.]	Oximeter	2016-11-28
PMN K133090 \| DQA DELBIO INCORPORATION [DELBio INC.]	O2Health fingertip pulse oximeter, Model: DB12	2016-11-28
PMN K133090 DELBIO INCORPORATION	OXICARE FINGERTIP PULSE OXIMETER	2014-02-28
PMN K122927 \| DQA TISENG LIN [DELBio INC.]	O2Health fingertip pulse oximeter	2013-12-02
PMN K122927 \| DQA TISENG LIN [DELBio INC.]	O2Health fingertip pulse oximeter, Model: DB11-B	2013-12-02
PMN K122927 \| DQA DELBIO INCORPORATION [DELBio INC.]	O2Health fingertip pulse oximeter	2013-12-02
PMN K122927 \| DQA DELBIO INCORPORATION [DELBio INC.]	O2Health fingertip pulse oximeter, Model: DB11-B	2013-12-02
PMN K132338 DELBIO INCORPORATION	DA01 BLOOD GLUCOSE MONITORING SYSTEM	2013-10-24
PMN K130244 DELBIO INCORPORATION	DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM	2013-08-23
PMN K122927 DELBIO INCORPORATED	OXICARE FINGERTIP PULSE OXIMETER	2012-12-20
PMN K120866 DELBIO INCORPORATION	DA01 BLOOD GLUCOSE MONITORING SYSTEM	2012-12-11
PMN K103329 DELBIO INCORPORATION	DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION	2012-03-13
PMN K113343 DELBIO INCORPORATION	DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM	2012-02-08
PMN K100806 DELBIO INCORPORATION	DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM	2011-09-16

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091179041	Taipei,China (Taiwan) -> Oakland, California	OCT OPTOVUE ISCAN 2.0 (OEM) WB PARTS OF OPTOV CE TOMOGRAPHY SYSTEM HS CODE 9018.50 3923.90 . .	33 CTN
2020090933942	Kaohsiung,China (Taiwan) -> Oakland, California	OCT OPTOVUE ISCAN2.0 (OEM) WB	6 CTN
2020061628646	Taipei,China (Taiwan) -> Oakland, California	OCT OPTOVUE ISCAN2.0 (OEM) WB	8 CTN
2020061561988	Taipei,China (Taiwan) -> Oakland, California	OCT OPTOVUE ISCAN2.0 (OEM) WB	8 CTN
2020052824599	Taipei,China (Taiwan) -> Oakland, California	PARTS OF OPHTHALMIC INSTRUMENTS	45 CTN
2019111833198	Shilong,China (Taiwan) -> Oakland, California	BRAKE OF OCT OPTOVUE ISCAN2.0	18 CTN
2019102835637	Kaohsiung,China (Taiwan) -> Oakland, California	DUMMY SAMPLE MICRO CT PRECLINICAL STANDARD DE RY	2 CAS
2019072228939	Shilong,China (Taiwan) -> Oakland, California	BRAKE OF OCT OPTOVUE	8 CTN