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Sign in to claim this brandWhat STERIMEDIX LIMITED makes
Sterimedix Limited manufactures single-use ophthalmic devices, including irrigation, infusion, and aspiration cannulae for surgical procedures, as well as non-illuminating ophthalmic needles and tissue injection cannulae. Their portfolio also covers lacrimal procedural cannulae, hypodermic needles, corneal markers, and surgical irrigation/aspiration handles designed for eye surgery. Specialized tools like hydrodissection cannulae, endothelial polishing cannulae, and formed cystotomes are also part of their product range.
All listed devices fall under FDA Class II regulation and are included in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States and adheres to U.S. regulatory requirements for these medical devices.
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 Sterimedix Limited manufacture?
Sterimedix Limited specializes in single-use ophthalmic devices. Their product range includes irrigation, infusion, and aspiration cannulae for surgical procedures, non-illuminating ophthalmic needles, tissue injection cannulae, lacrimal procedural cannulae, hypodermic needles, corneal markers, and surgical irrigation/aspiration handles. They also produce specialized tools like hydrodissection cannulae, endothelial polishing cannulae, and formed cystotomes, all designed for eye surgery.
Where is Sterimedix Limited based?
Sterimedix Limited is based in the United States. Their location aligns with the regulatory framework they follow for manufacturing and distributing their medical devices.
Which regulatory registries list Sterimedix Limited’s devices?
Sterimedix Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for Class II devices under U.S. regulatory requirements.
How are Sterimedix Limited’s devices classified under U.S. regulations?
All of Sterimedix Limited’s listed devices fall under FDA Class II classification. This classification is assigned based on the risk level of the devices, where Class II devices require special controls in addition to general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 504799313
Catalogue (164)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hydrodissection Cannulae | 3904-02/Y | FDA UDI | Class II | Active |
| Anaesthetic Needles | M0642-02/10 | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | M3900-02/100 | FDA UDI | Class II | Active |
| Intradermal Cannulae | AE1702-02/40 | FDA UDI | Class II | Active |
| Formed Irrigating Cystotomes | 3630-03/Y | FDA UDI | Class II | Active |
| Backflush Aspiration Handpieces | M4489A-02/5 | FDA UDI | Class II | Active |
| Bimanual I/A Systems | M5538-02/5 | FDA UDI | Class II | Active |
| Bimanual I/A Systems | 5531NS-02/Y | FDA UDI | Class II | Active |
| Refractive Cannulae | M2802-02/10 | FDA UDI | Class II | Active |
| Lachrymal Cannulae | M9272-02/10 | FDA UDI | Class II | Active |
| Formed Capsularhexis Cystotomes | 3626A-03/Y | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | M3904-02/100 | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | 3900-03NSP/Y | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | M3911-02/10 | FDA UDI | Class II | Active |
| Anaesthetic Needles | 0277-03/Y | FDA UDI | Class II | Active |
| Bimanual Cannulae and Hand Pieces | M5521-02/5 | FDA UDI | Class II | Active |
| Formed Capsularhexis Cystotomes | 3000F-03/Y | FDA UDI | Class II | Active |
| Wash Out Cannulae | 9280-03NSP/Y | FDA UDI | Class II | Active |
| Bimanual I/A Systems | M5331-02/5 | FDA UDI | Class II | Active |
| Formed Irrigating Cystotomes | M3610-02SP/10 | FDA UDI | Class II | Active |
| Formed Irrigating Cystotomes | M3610B-02SP/10 | FDA UDI | Class II | Active |
| Refractive Cannulae | M2804-02/10 | FDA UDI | Class II | Active |
| Refractive Cannulae | M2801-02/10 | FDA UDI | Class II | Active |
| Anaesthetic Cannulae | M0278-02/10 | FDA UDI | Class II | Active |
| Refractive Cannulae | M2824-02/10 | FDA UDI | Class II | Active |
| Viscoelastic Cannulae | M3927-02/10 | FDA UDI | Class II | Active |
| Lachrymal Cannulae | M9277-02/10 | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | 3902-02/Y | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | M3900-02/10 | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | M3920-02/10 | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | M3902-02/10 | FDA UDI | Class II | Active |
| Anaesthetic Needles | M0643-02/10 | FDA UDI | Class II | Active |
| Formed Irrigating Cystotomes | 3627A-03/Y | FDA UDI | Class II | Active |
| Vitreoretinal Cannulae | M4449-02/10 | FDA UDI | Class II | Active |
| Heavy Liquid Infusion Cannulae | M4452-02/10 | FDA UDI | Class II | Active |
| Intradermal Cannulae and Needles | AJ1850A-02/25 | FDA UDI | Class II | Active |
| Formed Irrigating Cystotomes | 3629-03/Y | FDA UDI | Class II | Active |
| Formed Irrigating Cystotomes | 3610-03P/Y | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | M2273D-02/100 | FDA UDI | Class II | Active |
| Anaesthetic Needles | 0642-03/Y | FDA UDI | Class II | Active |
| Lachrymal Cannulae | M9275-02/10 | FDA UDI | Class II | Active |
| Anterior Chamber Maintenance Cannulae | M2273B-02/10 | FDA UDI | Class II | Active |
| Vitreoretinal Handpieces | M4503-02/5 | FDA UDI | Class II | Active |
| Anaesthetic Needles | 0642A-03/Y | FDA UDI | Class II | Active |
| Cortex Removal Cannulae | M6575B-02/10 | FDA UDI | Class II | Active |
| Bimanual Cannulae and Hand Pieces | M5515-02/5 | FDA UDI | Class II | Active |
| Formed Irrigating Cystotomes | 3610B-02SP/Y | FDA UDI | Class II | Active |
| Hydrodissection Cannulae | M3906A-02/100 | FDA UDI | Class II | Active |
| Bimanual Cannulae and Hand Pieces | M5405-02/10 | FDA UDI | Class II | Active |
| Nucleus Removal Cannulae | M4620-02/10 | FDA UDI | Class II | Active |
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