[Sinskey II] Micro Lens Hook, angled
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- [Sinskey II] Micro Lens Hook, angled EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic surgical probe, single-use FDA UDI
- Device Name
- [Sinskey II] Micro Lens Hook, angled FDA UDI
- Model / Reference
- Manual Handled Instruments EUDAMED8200A EUDAMEDFDA UDI
- Description
- [Sinskey II] Micro Lens Hook, angled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516107011 EUDAMED00840516117515 EUDAMEDFDA UDI
- Basic UDI-DI
- 08405161820063 EUDAMED
- FDA Product Code
- HNQ FDA UDI
- EMDN Code
- Q021104 OPHTHALMIC SURGERY MANIPULATORS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic surgical probe, 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 surgical probe, single-use
[Sinskey II] Micro Lens Hook, angled by Psi/Eye-Ko, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 08405161820063 | 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 8ad2fc83-8247-4ab7-9d81-a952d28758cb 61 fields · synced Jul 26, 2026
- FDA UDI 1e9adcbf-f81c-4b86-ab9e-0f821be23c23 34 fields · synced May 30, 2026
- EUDAMED f7d0717b-aa87-4e6e-be19-7df32c04c42e 61 fields · synced Jul 26, 2026