Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPsi/Eye-Ko, Inc.
United States·US-MF-000022109
Last updated May 24, 2026
What Psi/Eye-Ko, Inc. makes
Psi/Eye-Ko, Inc. manufactures a range of ophthalmic surgical instruments, including cannulas for corneal procedures such as LASIK, infusion cannulas for intraocular applications, vitreoretinal micropicks for retinal surgery, and peribulbar needles for regional anesthesia delivery. Additional products include irrigating cystotomes for cataract surgery, capsule polishers for lens cleaning, and sub-Tenon cannulas for periocular injections.
The company’s devices are classified under EU Class IIa and are listed in the EU’s eudamed registry. While based in the United States, these products are designed to meet regulatory requirements for surgical instruments used in ophthalmic procedures.
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 Psi/Eye-Ko, Inc. manufacture?
Psi/Eye-Ko, Inc. specializes in ophthalmic surgical instruments. Their product range includes cannulas for corneal procedures like LASIK, infusion cannulas for intraocular applications, vitreoretinal micropicks for retinal surgery, peribulbar needles for regional anesthesia, irrigating cystotomes for cataract surgery, capsule polishers for lens cleaning, and sub-Tenon cannulas for periocular injections. These devices are designed for precision in eye surgeries.
Where is Psi/Eye-Ko, Inc. based, and how does this affect their devices?
Psi/Eye-Ko, Inc. is based in the United States. While their headquarters are in the US, their devices are engineered to comply with international regulatory standards, particularly those relevant to ophthalmic surgical instruments. This ensures their products meet the requirements of markets where they are distributed, including the EU.
Which regulatory registries list Psi/Eye-Ko, Inc.’s devices?
Psi/Eye-Ko, Inc.’s devices are listed in the eudamed registry, which is the European database for medical devices. This registry is used to track devices that have been authorized for placement on the EU market, ensuring transparency and traceability for healthcare professionals and regulators.
How are Psi/Eye-Ko, Inc.’s devices classified under EU regulations?
Psi/Eye-Ko, Inc.’s devices fall under EU Class IIa, which is the second-lowest risk classification for medical devices. This classification applies to instruments that pose a moderate risk to patients, such as certain surgical tools used in ophthalmology. Class IIa devices require compliance with specific EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, including clinical evaluations and risk management processes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 804, Corporate Centre Drive, O'Fallon, United States
- Website
- www.anodynesurgical.com
- —
- —
- [email protected]
- Phone
- 800-428-5628
- PRRC Contact
- Valerie Anderson
- EUDAMED SRN
- US-MF-000022109
- FDA FEI Number
- —
- DUNS Number
- 063763833
Catalogue (2039)
Page 39 of 41| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Anodyne Surgical | 8600 | FDA UDI | Class I | Active |
| Anodyne Surgical | 8050C | FDA UDI | Class I | Active |
| Anodyne Surgical | 5000AF | FDA UDI | Class I | Active |
| Anodyne Surgical | 1006-12 | FDA UDI | Class I | Active |
| Anodyne Surgical | 9603-3 | FDA UDI | Class I | Active |
| Anodyne Surgical | 0004HS | FDA UDI | Class I | Active |
| Anodyne Surgical | 2003-11(25) | FDA UDI | Class I | Active |
| Walcott Rx Products | Rx9033 | FDA UDI | Class I | Active |
| Anodyne Surgical | 1004-8 | EUDAMEDFDA UDI | Class I | Active |
| Anodyne Surgical | 1001-2 | FDA UDI | Class I | Active |
| Anodyne Surgical | 1000-8 | FDA UDI | Class I | Active |
| Anodyne Surgical | 4001-17L | EUDAMEDFDA UDI | Class I | Active |
| Anodyne Surgical | 6000-22 | FDA UDI | Class I | Active |
| Walcott Rx Products | Rx8501 | FDA UDI | Class I | Active |
| Anodyne Surgical | 9010ATS | EUDAMEDFDA UDI | Class I | Active |
| Walcott Rx Products | Rx1003-8 | FDA UDI | Class I | Active |
| Anodyne Surgical | 0001F | FDA UDI | Class I | Active |
| Anodyne Surgical | 4003C | FDA UDI | Class I | Active |
| Anodyne Surgical | 8200S | FDA UDI | Class I | Active |
| Anodyne Surgical | 0007 | FDA UDI | Class I | Active |
| Anodyne Surgical | 8404P | FDA UDI | Class I | Active |
| Anodyne Surgical | 9007 | FDA UDI | Class I | Active |
| Anodyne Surgical | 8503 | EUDAMEDFDA UDI | Class I | Active |
| Anodyne Surgical | KA2276 | FDA UDI | Class I | Active |
| Anodyne Surgical | 5001AF | EUDAMEDFDA UDI | Class I | Active |
| Anodyne Surgical | AFK-0001 | FDA UDI | Class I | Active |
| Walcott Rx Products | Rx9006 | FDA UDI | Class I | Active |
| Anodyne Surgical | AFK-0005 | FDA UDI | Class I | Active |
| Anodyne Surgical | 7010 | EUDAMEDFDA UDI | Class I | Active |
| Anodyne Surgical | 1002-10 | EUDAMEDFDA UDI | Class I | Active |
| Anodyne Surgical | KA2274 | FDA UDI | Class I | Active |
| Anodyne Surgical | 7009B | FDA UDI | Class I | Active |
| Anodyne Surgical | 8603 | FDA UDI | Class I | Active |
| Anodyne Surgical | 4006 | FDA UDI | Class I | Active |
| Anodyne Surgical | 8204 | FDA UDI | Class I | Active |
| Anodyne Surgical | 4003M | FDA UDI | Class I | Active |
| Anodyne Surgical | 0004H | FDA UDI | Class I | Active |
| Anodyne Surgical | 2004-9 | FDA UDI | Class I | Active |
| Anodyne Surgical | CT6001 | FDA UDI | Class I | Active |
| Walcott Rx Products | Rx1004-6 | FDA UDI | Class I | Active |
| Anodyne Surgical | 3008 | FDA UDI | Class I | Active |
| Anodyne Surgical | 5003AF.5 | FDA UDI | Class I | Active |
| Anodyne Surgical | 9025-25 | EUDAMEDFDA UDI | Class I | Active |
| Walcott Rx Products | Rx5197 | FDA UDI | Class I | Active |
| Anodyne Surgical | 7015 | EUDAMEDFDA UDI | Class I | Active |
| Anodyne Surgical | 8601 | FDA UDI | Class I | Active |
| Anodyne Surgical | 0008 | FDA UDI | Class I | Active |
| Anodyne Surgical | 0020.2 | FDA UDI | Class I | Active |
| Anodyne Surgical | 1007-10 | FDA UDI | Class I | Active |
| Anodyne Surgical | 8000-25(12S) | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.