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Sign in to claim this brandRocket Medical Plc
US
Last updated May 27, 2026
What Rocket Medical Plc makes
The company manufactures single-use and reusable medical devices for gynecological procedures, including intrauterine curettes and suction systems for uterine tissue removal, as well as catheter sets for assisted reproduction and pneumothorax drainage. It also produces IVF-specific tools such as oocyte aspiration needles and needle guides, alongside reusable cervical dilators and intrauterine imaging catheters. Electrocautery system electrodes for surgical precision are part of its portfolio, catering to both reproductive and thoracic applications.
The portfolio includes devices classified under FDA regulations as Class I and Class II, with authorisations granted through 510(k) clearances and Unique Device Identifiers (UDIs). These products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device standards. The company operates from the United States, adhering to domestic regulatory requirements for these categories.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Rocket Medical Plc manufacture?
Rocket Medical Plc specializes in medical devices primarily used in gynecological and reproductive procedures. Their portfolio includes single-use and reusable devices such as intrauterine curettes and suction systems for uterine tissue removal, catheter sets for assisted reproduction and pneumothorax drainage, IVF-specific tools like oocyte aspiration needles and needle guides, reusable cervical dilators, intrauterine imaging catheters, and electrocautery system electrodes. These devices cater to both reproductive health and thoracic applications.
Where is Rocket Medical Plc based, and how does this affect its regulatory compliance?
Rocket Medical Plc is based in the United States, which means its devices must comply with U.S. regulatory requirements. Since the company’s products fall under FDA classifications—such as Class I and Class II—they undergo evaluation through processes like 510(k) clearances and Unique Device Identifier (UDI) registration to ensure adherence to U.S. medical device standards.
Which regulatory databases list Rocket Medical Plc’s devices?
Rocket Medical Plc’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) clearance process and Unique Device Identifier (UDI) registration. These listings confirm that the devices meet U.S. regulatory requirements for their respective classifications, ensuring traceability and compliance.
How are Rocket Medical Plc’s devices classified under FDA regulations?
Rocket Medical Plc’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose the lowest risk and may require less stringent regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) clearance or other authorisation processes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- rocketmedical.com
- —
- —
- [email protected]
- Phone
- +4401914196988
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 544313588
Catalogue (236)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rocket | R51411 | FDA UDI | N/A | Active |
| Rocket | R51400-00-PP | FDA UDI | N/A | Active |
| Rocket | R54410-00-VV | FDA UDI | N/A | Active |
| Rocket | R57602 | FDA UDI | N/A | Active |
| Rocket | R57603-SC-70 | FDA UDI | N/A | Active |
| Rocket | R57602-TX-70 | FDA UDI | N/A | Active |
| Rocket | R54701 | FDA UDI | Class I | Active |
| Rocket | R59525 | FDA UDI | N/A | Active |
| Rocket | R57630-EC-23 | FDA UDI | N/A | Active |
| Rocket | R57804 | FDA UDI | N/A | Active |
| Rocket | R57975 | FDA UDI | N/A | Active |
| Rocket | R57603-SX-70 | FDA UDI | N/A | Active |
| Rocket | R57424-00-ST | FDA UDI | N/A | Active |
| Rocket | R57976 | FDA UDI | N/A | Active |
| Rocket | R57422-00-ST | FDA UDI | N/A | Active |
| Rocket | R57678 | FDA UDI | N/A | Active |
| Rocket | R57422 | FDA UDI | N/A | Active |
| Hystalog Hsg Catheter | K000340 | FDA 510(k) | Class II | Active |
| Guidewires | K042264 | FDA 510(k) | Class II | Active |
| Neurotherm Rf Cannula | K994344 | FDA 510(k) | Class II | Active |
| Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | K162457 | FDA 510(k) | Class II | Active |
| Craft Duo-Vac Suction Unit And Craft Suction Unit | K000394 | FDA 510(k) | Class II | Active |
| Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack And Bottle Set, Rocket Ipc Drainage B | K123033 | FDA 510(k) | Class II | Active |
| Cervineedle Disposable Cartridge Syringe | K052365 | FDA 510(k) | Class II | Active |
| Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | K152105 | FDA 510(k) | Class II | Active |
| Embryon Single And Double Lumen Needles | K000205 | FDA 510(k) | Class II | Active |
| Embryon Ultrasound Needle Guide | K032015 | FDA 510(k) | Class II | Active |
| Endometrial Sampling Syringe | K040189 | FDA 510(k) | Class II | Active |
| Ultra-Fine Diathermy Loop And Coagulation Balls | K972856 | FDA 510(k) | Class II | Active |
| Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet For Embryon Intrauter | K980061 | FDA 510(k) | Class II | Active |
| Embryon Transfer Catheters/Sets | K994327 | FDA 510(k) | Class II | Active |
| Craft Duo-Vac Suction Unit, Craft Suction Unit | K972867 | FDA 510(k) | Class I | Active |
| Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | K163321 | FDA 510(k) | Class II | Active |
| Embryon Gift Transfer Catheters/Sets | K000656 | FDA 510(k) | Class II | Active |
| Rocket Pleuraseal Ii Chest Drainage System | K961287 | FDA 510(k) | Class II | Active |
| Rocket Platinum Cured Cathter | K210509 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Rocket Medical Plc WASHINGTON Sunderland · GB FEI 3002808026