Identity
- Trade Name
- UNITY EUDAMEDFDA UDI
- Generic Name
- Vitrectomy system micro-cutting unit FDA UDI
- Device Name
- Vitrectomy Probes EUDAMED25+ ULTRAVIT 10K Probe FDA UDI
- Model / Reference
- 8065753176 EUDAMED00380657531769 FDA UDI
- Description
- 25+ ULTRAVIT 10K Probe FDA UDI
Identifiers
- Catalog Number
- 8065753176 FDA UDI
- Primary DI / UDI-DI
- 00380657531769 EUDAMEDFDA UDI
- Basic UDI-DI
- 038065GMN000073H6 EUDAMED
- FDA Product Code
- MLZ FDA UDI
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Vitrectomy system micro-cutting unit FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4150 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Phacoemulsification system handpiece tip, single-use
Unity by Alcon Laboratories, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification system handpiece tip, single-use.
- LAMINAR — Johnson & Johnson Surgical Vision, Inc. · Class II
- CANNULA — MED LOGICS INC · Class IIa
- Sterile Light Fibers — Vitreq B.V. · Class IIa
- 2.8 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- AMO PHACO NEEDLE — Johnson & Johnson Surgical Vision, Inc. · Class II
- Sterile Ophthalmic Surgical Procedure Pack — Vitreq B.V. · Class IIa
- Sterile Viscous Fluid Injection / Extraction Tool — Vitreq B.V. · Class IIa
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038065GMN000073H6 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
- EUDAMED SRN
- US-MF-000016248
- Authorised Representative
- Alcon Laboratories Belgium BE-AR-000014721
Sources (2)
- EUDAMED 7986f315-f290-4be2-8f25-3a2ede6460b1 61 fields · synced Jul 23, 2026
- FDA UDI 8831366e-7c44-4d60-b516-4c429ed848bd 35 fields · synced May 29, 2026