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Marco

FDA UDI

Class II (US FDA UDI)

by Takagi Seiko Co., Ltd.

Identity

Trade Name
MARCO FDA UDI
Generic Name
Ophthalmic examination slit lamp FDA UDI
Device Name
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capusule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment. FDA UDI
Model / Reference
MARCO 5 ULTRA SLITLAMP FDA UDI
Description
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capusule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment. FDA UDI

Identifiers

Primary DI / UDI-DI
06909071671185 FDA UDI
510(k) Number
K930438 FDA UDI
FDA Product Code
HJO FDA UDI
GMDN Term
Ophthalmic examination slit lamp FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1850 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

Marco by Takagi Seiko Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Takagi Seiko Co., Ltd.

Sources (1)

  • FDA UDI 153d0a2a-5610-4419-88e0-0fe425094903 36 fields · synced May 30, 2026