Polycore Optical M Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Polycore Optical M Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9617438
• FEI Number: 1000268442
• Name: SWEA NIGHTIINGALE
• Owner & Operator: POLYCORE OPTICAL (M) SDN BHD
• Contact Address: LOT PLO 23, KAWASAN PERINDUSTRIAN SENAI; SENAI MY-01 Johor 81400 MY
• Official Correspondent:
  • NORLEE TUMIRAN
  • 60-7-5991516-x
• US Agent:
  • SWEA NIGHTIINGALE
  • THE VISION COUNCIL
  • 703 5484560 0
  • 703 5484580
  • fda@thevisioncouncil.org
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 225 REINEKERS LANE SUITE 700; Alexandria, VA 22314 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
HQG SWEA NIGHTIINGALE [POLYCORE OPTICAL (M) SDN BHD]	POLYCORE LENSES	1998-11-20

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200918459	Singapore,Singapore -> Los Angeles, California	OPHTHALMIC LENSES	27 PCS
2020071027472	Singapore,Singapore -> Los Angeles, California	OPHTHALMIC LENSES	27 PCS
2020011626835	Singapore,Singapore -> Long Beach, California	PLASTICS LENSES .	32 CTN
2018120858313	Xiamen,China (Mainland) -> Los Angeles, California	POLYMERIZATION OVERN SHIPPER'S LOAD STOW AND COUNT 4 PACKAGES OF POLYMERIZATION OVERN	4 PKG
20180120426	Singapore,Singapore -> Los Angeles, California	OPHTHALMIC LENSES	231 BOX