FDA Registration Active 🇬🇧 United Kingdom

ROCKET MEDICAL PLC

Reg #: 9610632 · FEI: 3002808026 · Expires 2026
Products
16
Proprietary Names
58
Establishment Types
2
Classifications
16

Registration Details

Registration Name
ROCKET MEDICAL PLC
Registration Number
9610632
FEI Number
3002808026
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Sedling Road
City
WASHINGTON Sunderland
Country
GB

Regulatory Submissions

510(k) Number
K994327

Owner / Operator

Firm Name
Rocket Medical Plc
Operator Number
8010022
Address
Sedling Road, --
City
Washington
State
Sunderland
Postal Code
NE38 9BZ
Country
GB

US Agent

Business Name
Rocket Medical LLC
Contact Name
Toby Tyson
Address
50 Corporate Park Drive, Suite 890
City
Pembroke
State
MA
ZIP
02359
Country
US
Phone
781 7496223

Products

Device Name Product Code
Catheter, Assisted Reproduction MQF
Bottle, Collection, Vacuum KDQ
Bulb, Inflation, For Endoscope FCY
Needle, Assisted Reproduction MQE
System, Imaging, Pulsed Echo, Ultrasonic IYO
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
Catheter, Irrigation GBX
Tubing And Tubing/Filter Fits NVT
Accessory, Assisted Reproduction MQG
Electrode, Circular (Spiral), Scalp And Applicator HGP
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Chest Drainage Kit PAD
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) HES
Apparatus, Suction, Patient Care DWM
Cannula, Intrauterine Insemination MFD

Proprietary Names

ET Catheters #K994327 For the placement of embryos Heimlich Valve IPC Bottles and accessories Pleural Vent R53902 Disposable Sigmoidoscope Insufflation Sets Rocket Medical Needle Guides Rocket Peritoneal Catheter & Accessories Thoracentesis Seldinger Chest Drain Kit R54544-12-00 / 18-00 etc Thoracic Catheters Pleural Drain Set Needle Drains Blunt Dissection Kits R58800 Range - Drainage Catheters Chest Aspiration Set IVF Devices Aspiration & Collection #K000205 R57687 Filter Set for Cook K-MAR 5200 Pump R57685 Water Trap Set for CRAFT Suction Pumps R57686 Filter Set for Oocyte Aspiration Pump #K000394 R29660 CRAFT DUO VAC Suction Pump (240V) R29661 CRAFT DUO VAC Suction Pump (110v) R57008-00-CN Copeland Foetal Scalp Electrode for Qwik Connect Cables #K844608 R57008-00-FM Copeland Foetal Scalp Electrode for Philips Avalon Cables #K972867 R29654 CRAFT Suction Pump (110v) R29655 CRAFT Suction Pumps (240V) R51401-DP R51411-00-PP R51401 R51411 R51401-00-PP R51400-00-PP R51400-DP R51400 Drainage Bottle #K000340 R57422-00-PK HSG Procedure Pack 5Fg R57424-00-PK HSG Procedure Pack 7Fg R57422 HSG & HyCoSy Catheter 5Fg R57430-CONE Hysterocone - 6Fg HSG & HyCoSy Catheter R57422-ST-PK HSG Procedure Pack - 5Fg with Stylet R57424 HSG & HyCoSy Catheter 7Fg R57422-00-ST HSG & HyCoSy Catheter with Stylet 5Fg R57424-ST-PK HSG Procedure Pack - 7Fg with Stylet R57424-00-ST HSG & HyCoSy Catheter with Stylet 7Fg Rocket Indwelling Pleural Catheter (IPC) System Including Bottles, bags, insertion sets #K980061 R57625 Embryon DUO IUI Catheter 18cm R57625-00-23 Embryo DUO IUI Catheter 23cm R57622 Embryon EDL IUI Catheter 18cm

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device