Unicon Optical Co L T D

FDA Filings

This page includes the latest FDA filings for Unicon Optical Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Unicon Optical Co L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• UNICON OPTICAL CO., LTD.

FDA Registration(s)

• Registration Number: 3013170070
• FEI Number: 3013170070
• Name: UNICON OPTICAL CO., LTD.
• Owner & Operator: Unicon Optical Co., Ltd.
• Contact Address: No.16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township; Hsinchu County TW-NOTA 30075 TW
• Official Correspondent:
  • Karen Chung
  • 886-3-5775586-x
• US Agent:
  • Ho Shan Wang
  • 623 9864377
  • acmebiotechs@gmail.com
• Importing Logistics Registration:
  • Importer: Unicon Optical Co., Ltd.
  • Address: No.16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township ; Hsinchu County, 30075 TAIWAN
  • Subdivision: TW-NOTA
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No.16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township; Hsinchu County Hsinchu - District, 30075 TW
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3016244603
• FEI Number: 3016244603
• Name: Unicon Optical Co., Ltd. (Taichung Jingke Factory)
• Owner & Operator: Unicon Optical Co., Ltd.
• Contact Address: No.16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township; Hsinchu County TW-NOTA 30075 TW
• Official Correspondent:
  • Karen Chung
  • 886-3-5775586-x
• US Agent:
  • Ho Shan Wang
  • 623 9864377
  • acmebiotechs@gmail.com
• Importing Logistics Registration:
  • Importer: ZonedIn Vision LLC
  • Address: Mc Allen, TX 78504, USA ; McAllen, TX 78504 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: NO.11 & 4F NO.11, JINGKE CENTRAL 1ST RD., NANTUN DIST., TAICHUNG ; TAICHUNG Taichung - District, 40852 TW
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04719881883768 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883751 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883744 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883737 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883720 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883713 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883706 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883690 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883683 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883676 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883669 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883652 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883645 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883638 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883621 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883614 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883607 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883591 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883584 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883577 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883560 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883553 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883546 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883539 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883522 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883515 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883508 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883492 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883485 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883478 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883461 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883454 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883447 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883430 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883423 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883416 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883409 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883393 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883386 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883379 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883362 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883355 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883348 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883331 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883324 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883317 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883300 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883294 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883287 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883270 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883263 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883256 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883249 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883232 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883225 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883218 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883201 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883195 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719881883188 Unicon Optical Co., Ltd.	Qualis	2023-08-09
GUDID 04719880078882 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078875 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078868 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078851 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078844 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078837 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078820 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078813 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078806 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078783 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078776 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078769 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078752 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078745 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078738 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078721 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078714 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078707 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078691 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078684 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078677 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078660 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078653 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078646 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078639 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078622 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078615 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078608 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078592 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078585 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078578 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078561 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078554 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078547 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078530 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078523 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078516 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078509 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078493 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078486 Unicon Optical Co., Ltd.	Qualis	2022-07-11
GUDID 04719880078479 Unicon Optical Co., Ltd.	Qualis	2022-07-11
PMN K191929 | MVN Unicon Optical Co., Ltd. (Taichung Jingke Factory) [Unicon Optical Co., Ltd.]	To be notified	2019-11-13
PMN K191929 | MVN UNICON OPTICAL CO., LTD.	To be notified	2019-11-13
PMN K191929 | LPL Unicon Optical Co., Ltd. (Taichung Jingke Factory) [Unicon Optical Co., Ltd.]	To be notified	2019-11-13
PMN K191929 | LPL UNICON OPTICAL CO., LTD.	To be notified	2019-11-13
PMN K191929 UNICON Optical CO., LTD	UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens	2019-09-17
PMN K182734 UNICON Optical CO., LTD	Unicon Hydrogel With Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac	2019-05-16
PMN K083288 | MVN UNICON OPTICAL CO., LTD.	To be notified	2018-09-11
PMN K083288 | LPL UNICON OPTICAL CO., LTD.	To be notified	2018-09-11
PMN K073060 | MVN UNICON OPTICAL CO., LTD.	To be notified	2018-09-11
PMN K073060 | LPL UNICON OPTICAL CO., LTD.	To be notified	2018-09-11
PMN K141917 | MVN UNICON OPTICAL CO., LTD.	Unicon (Etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear	2016-10-13
PMN K141917 | LPL UNICON OPTICAL CO., LTD.	Unicon (Etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear	2016-10-13
PMN K141917 UNICON OPTICAL CO., LTD.	UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR	2014-10-17

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092654515	Shilong,China (Taiwan) -> Los Angeles, California	SOFT CONTACT LENS 23 PLTS 603 CTNS HS CODE 90 . .	603 CTN
2020080669716	Taipei,China (Taiwan) -> Los Angeles, California	SOFT CONTACT LENS 4 PLTS = 64 CTNS HS CODE 9 . .	64 CTN
2020071834153	Taipei,China (Taiwan) -> Los Angeles, California	SOFT CONTACT LENS 9 PLTS = 254 CTNS HS CODE . .	254 CTN
2020062546047	Shilong,China (Taiwan) -> Los Angeles, California	SOFT CONTACT LENS 20 PLTS = 428 CTNS HS CODE . .	428 CTN
2020042939248	Shilong,China (Taiwan) -> Los Angeles, California	SOFT CONTACT LENS	376 CTN
2020041849539	Taipei,China (Taiwan) -> Los Angeles, California	SIMPLIFEYES DAILY DISPOSABLE CONTACT LENS HS CODE: 9001.30	12 CTN
2020010353645	Taipei,China (Taiwan) -> Los Angeles, California	SIMPLIFEYES DAILY DISPOSABLE CONTACT LENS HS CODE: 9001.30	11 CTN
2019101759237	Kaohsiung,China (Taiwan) -> Los Angeles, California	SIMPLIFEYES DAILY DISPOSABLE CONTACT LENS H.S .	18 CTN