Capsule Polisher 21g, side port
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Capsule Polisher 21g, side port EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Capsule Polisher 21g, side port FDA UDI
- Model / Reference
- Capsule Polishers EUDAMED6000 EUDAMEDFDA UDI
- Description
- Capsule Polisher 21g, side port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516105529 EUDAMED00840516116907 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840516160005B EUDAMED
- FDA Product Code
- MXY FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Capsule Polisher 21g, side port by Psi/Eye-Ko, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840516160005B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- PSI/EYE-KO, Inc.
- EUDAMED SRN
- US-MF-000022109
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 525a9eb0-ad24-4826-a792-c7f7df70ac8a 61 fields · synced Jul 31, 2026
- FDA UDI d8877329-4975-4348-87c7-28efb4f4e282 34 fields · synced May 30, 2026
- EUDAMED a20ee940-04bc-4d88-9a03-1d53f30b28b7 61 fields · synced Jul 31, 2026