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EVA NEXUS™, Phaco vitrectomy system

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
EVA NEXUS™, Phaco vitrectomy system FDA UDI
Generic Name
Phacoemulsification/vitrectomy system FDA UDI
Model / Reference
9000.COMU1 FDA UDI

Identifiers

Primary DI / UDI-DI
08717872034423 FDA UDI
510(k) Number
K213467 FDA UDI
FDA Product Code
HQC FDA UDI
HQE FDA UDI
GMDN Term
Phacoemulsification/vitrectomy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4670 FDA UDI
886.4150 FDA UDI
Commercial Distribution
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

Category: Phacoemulsification/vitrectomy system

EVA NEXUS™, Phaco vitrectomy system by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Phacoemulsification/vitrectomy system.

Cleared under the same submission

K213467 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 5f30fc2e-2b98-4894-bdde-438eb1e36be5 33 fields · synced Jun 1, 2026