MICS 1.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x r

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: MICS 1.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x r FDA UDI
Generic Name: Phacoemulsification system handpiece FDA UDI
Model / Reference: 3430.18AF1 FDA UDI

Identifiers

Primary DI / UDI-DI: 08717872033006 FDA UDI
FDA Product Code: HQC FDA UDI
GMDN Term: Phacoemulsification system handpiece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4670 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Phacoemulsification system handpiece

MICS 1.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x r by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II…

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

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

Sources (1)

FDA UDI f2cea0d5-9f3b-48a6-8736-dd19ab7569e6 32 fields · synced May 29, 2026