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EVA, combined machine including Laser (SMA connector)

FDA UDI

Class II (US FDA UDI)

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Identity

Trade Name
EVA, combined machine including Laser (SMA connector) FDA UDI
Generic Name
Phacoemulsification/vitrectomy system FDA UDI
Model / Reference
8000.COM03 FDA UDI

Identifiers

Catalog Number
8000.COM03 FDA UDI
Primary DI / UDI-DI
08717872019666 FDA UDI
510(k) Number
K142877 FDA UDI
FDA Product Code
HQF FDA UDI
HQE FDA UDI
HQC FDA UDI
GMDN Term
Phacoemulsification/vitrectomy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4390 FDA UDI
886.4150 FDA UDI
886.4670 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

EVA, combined machine including Laser (SMA connector) by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA…

Cleared under the same submission

K142877 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Sources (1)

  • FDA UDI 0c68665e-34d2-4878-8303-0fd49e6a3ae0 35 fields · synced May 30, 2026