Scandinavian Health L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 9681538
• FEI Number: 3004483565
• Name: SCANDINAVIAN HEALTH LTD.
• Owner & Operator: SCANDINAVIAN HEALTH LTD.
• Contact Address: NO.36, Liufu Rd, Luzhu District, ; TAOYUAN CITY TW-TAO Taoyuan 338 TW
• Official Correspondent:
  • Ping Fan
  • 886-3-2170303-3169
• US Agent:
  • Don Rogers
  • Managing Director
  • 954 7252107
  • 954 7252009
  • Don.Rogers@shl-group.com
• Importing Logistics Registration:
  • Importer: SHL Pharma LLC
  • Address: 588 Jim Moran Blvd ; Deerfield Bch, FL 33442 UNITED STATES
  • Importer Type: Temporary storage for stock rotation
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: NO. 136 KUO SHENG 2ND STREET ; TAOYUAN CITY Taoyuan, 330 TW
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K141384 SCANDINAVIAN HEALTH LIMITED	WHISPERJECT AUTOINJECTOR	2014-09-12
PMN K124026 SCANDINAVIAN HEALTH LIMITED	LOBSTER AUTO-INJECTOR	2013-09-13
PMN K120191 SCANDINAVIAN HEALTH LIMITED	PUSH-ON NEEDLE 30GX8MM	2012-05-23
PMN K954729 SCANDINAVIAN HEALTH LTD.	PEN-INJECT 2.25	1996-01-29

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009233672	Pusan,South Korea -> Miami, Florida	MOLLY RNS-DP BODY RNS SUB-ASSEMBLY 61,440PCS MOLLY RNS-DP POWER PACK SUB-ASSEMBLY 62,720PCS HS CODE 9018.31 480CTNS=15PALLETS	480 CTN
202008101575	Pusan,South Korea -> Miami, Florida	MOLLY RNS-DP BODY RNS SUB-ASSEMBLY 61,440PCS MOLLY RNS-DP POWER PACK SUB-ASSEMBLY 62,720PCS 480CTNS=15 PLTS HS CODE 9018.31	480 CTN
202007077281	Kaohsiung,China (Taiwan) -> Norfolk, Virginia	REAR ASSEMBLY,LIGHT BLUE,0.5ML 285,120 PCS FR ONT ASSEMBLY,	549120 PCS
202006295638	Kaohsiung,China (Taiwan) -> Norfolk, Virginia	REAR ASSEMBLY,LIGHT BLUE,0.5ML 285,120 PCSFRO NT ASSEMBLY,	549120 PCS
202006226591	Kaohsiung,China (Taiwan) -> Norfolk, Virginia	REAR ASSEMBLY,LIGHT BLUE,0.5ML 285,120 PCSFRO NT ASSEMBLY,	549120 PCS
202006151345	Pusan,South Korea -> Miami, Florida	480CTNS=15 PLTS MOLLY RNS-DP BODY RNS SUB-ASSEMBLY 61,440PCS MOLLY RNS-DP POWER PACK SUB-ASSEMBLY 62,720PCS HS CODE 9018.31	480 CTN
202006155337	Kaohsiung,China (Taiwan) -> Norfolk, Virginia	REAR ASSEMBLY, LIGHT BLUE,0.5ML 155,520 PCS F RONT ASSEMBLY,	472320 PCS
202006085886	Kaohsiung,China (Taiwan) -> Norfolk, Virginia	REAR ASSEMBLY,LIGHT BLUE,0.5ML 285,120 PCSFRO NT ASSEMBLY,	549120 PCS