Arjo Suzhou Co L T D

FDA Filings

This page includes the latest FDA filings for Arjo Suzhou Co 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: 3005619970
• FEI Number: 3005619970
• Name: Arjo (Suzhou) Co., Ltd.
• Owner & Operator: ARJOHUNTLEIGH AB
• Contact Address: Hans Michelsensgatan 10 ; Malmo SE-M Skane lan [SE-12] 211 20 SE
• US Agent:
  • Ruby Upadhyaya
  • Arjo Inc
  • 630 7854747
  • ruby.upadhyaya@arjo.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No. 158 Fangzhou Road SIP, Suzhou, Jiangsu,; Suzhou Jiangsu, 215024 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K172103 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FLOWTRON DVT5 GARMENT (SUZHOU-CONTRACT MFR., POZNAN-SPEC. DEV. & COMPLAINTS)	2018-03-05
PMN K152228 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	Hydroven 12 Pump (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS,SUZHOU- CONTRACT MFR)	2016-08-23
PMN K152228 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	Hydroven 12 Garments (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS, POZNAN - CONTRACT MFR)	2016-08-23
PMN K143438 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FLOWTRON ACS900 PUMP OPERATING ROOM (SUZHOU- MFR., POZNAN - COMPLAINTS)	2015-06-25
PMN K143438 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FLOWTRON ACS900 PUMP (SUZHOU - MFR., POZNAN - COMPLAINTS)	2015-06-25
PMN K010744 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FLOWTRON UNIVERSAL AC600OR PUMP (POZNAN - COMPLAINTS)	2008-03-04
PMN K010744 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FLOWTRON UNIVERSAL AC600 PUMP (POZNAN - COMPLAINTS)	2008-03-04
PMN K961166 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	L503-M GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)	2007-12-05
PMN K961166 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	L501-M GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)	2007-12-05
PMN K961166 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FLOWTRON EXCEL PUMP (POZNAN - MFR & COMPLAINTS, SUZHOU - CONTRACT MFR.)	2007-12-05
PMN K961166 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	DVT40 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)	2007-12-05
PMN K961166 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	DVT30 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)	2007-12-05
PMN K961166 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	DVT20 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)	2007-12-05
PMN K961166 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	DVT10 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)	2007-12-05
PMN K910188 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	HYDROVEN GARMENTS (POZNAN - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)	2007-12-05
PMN K910188 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	HYDROVEN FPR PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)	2007-12-05
PMN K910188 | JOW Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	HYDROVEN 3 PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)	2007-12-05
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	THERAKAIR VISIO PUMP (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	THERAKAIR VISIO MATTRESS (SUZHOU - MFR; POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	PROFICARE (POZNAN COMPLAINTS ONLY)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	NIMBUS PRO MATTRESS (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	NIMBUS 4 PUMP (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	NIMBUS 4 MATTRESS ASSEMBLY RELIANT IS2 (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	NIMBUS 3 PUMP (POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	NIMBUS 3 MATTRESS (POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	MAXXAIR ETS (POZNAN COMPLAINTS ONLY)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FIRST STEP SELECT PUMP (SUZHOU - MANUFACTURER; POZNAN - COMPLAINTS; )	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FIRST STEP SELECT MATTRESSES (SUZHOU-SPEC. DEVELOPER, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FIRST STEP SELECT HD(SUZHOU-SPEC. DEVELOPER, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FIRST STEP PLUS (POZNAN SPEC. DEVELOPER & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FIRST STEP CIRRUS OVERLAY (SUZHOU-SPEC. DEVELOPER; POZNAN COMPLAINTS ONLY)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	FIRST STEP ALL IN ONE (POZNAN SPEC. DEVELOPER & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	CITADEL CONTROL UNIT AND MATTRESS (POZNAN - SPEC. DEVELOPER, COMPLAINTS, FOREIGN EXP)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	BUBBLE PAD MATTRESS (POZNAN SPEC. DEVELOPER & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	BREEZE PUMP (POZNAN SPEC. DEVELOPER & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	BREEZE MATTRESS (POZNAN SPEC. DEVELOPER & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	AUTOLOGIC PUMP (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	AUTOLOGIC MATTRESS COVER (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	AURALIS PUMP (SUZHOU ? MFR, POZNAN ? COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	AURALIS MATTRESSES (SUZHOU ? MFR, POZNAN ? COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	AURA PUMP (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	AURA LOGIC CUSHION (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	AURA CUSHION (SUZHOU - MFR, POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ATMOSAIR APOD (POZNAN SPEC. DEVELOPER & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ATMOSAIR 9000AR (POZNAN - SPEC. DEVELOPER & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ATMOSAIR 9000A (POZNAN SPEC. DEVELOPER & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ATMOSAIR (POZNAN COMPLAINTS ONLY)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ALPHA TRANCELL DELUXE PUMP (SUZHOU - MFR; POZNAN - COMPLAINTS ONLY)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ALPHA RESPONSE PUMP (POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ALPHA RESPONSE MATTRESS (POZNAN - COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ALPHA RELIEF COVER (POZNAN - COMPLAINTS ONLY)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ALPHA ACTIVE MATTRESS (POZNAN - MFR & COMPLAINTS)	2002-08-15
FNM Arjo (Suzhou) Co., Ltd. [ARJOHUNTLEIGH AB]	ACER PORTABLE LATERAL ROTATION SYSTEM (POZNAN SPEC.DEVELOPER & COMPLAINTS)	2002-08-15

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092997248	Shanghai ,China (Mainland) -> Seattle, Washington	ALUMINUM DIE CASTINGCHANGHENG	106 CTN
2020091868955	Shanghai ,China (Mainland) -> Seattle, Washington	ALUMINUM DIE CASTINGCHANGHENG	106 CTN
2020090473930	Shanghai ,China (Mainland) -> Seattle, Washington	ALUMINUM DIE CASTING CHANGHENGSARA FOOT PLAT E YIDA WIRE HARNESS HOWDY	205 CTN
2020082457823	Shanghai ,China (Mainland) -> Los Angeles, California	AIR PUMPS AIR COMPRESSORS	44 CTN
2020081936057	Shanghai ,China (Mainland) -> Houston, Texas	SPARE PARTS OF MEDICAL EQUIPMENT	20 PKG
2020080654011	Shanghai ,China (Mainland) -> Long Beach, California	FIRST STEP SELECT-TOP ACS900 US STD TUBE SET BATTERY NDA SPARE PARTS OF MEDICAL EQUIPMENT	19 PKG
2020071513973	Shanghai ,China (Mainland) -> Houston, Texas	SPARE PARTS OF MEDICAL EQUIPMENT	17 PKG
2020071523525	Shanghai ,China (Mainland) -> Long Beach, California	FIRST STEP SELECT TOP SPARE PARTS OF MEDICAL EQUIPMENT	2 PKG