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MeniconZ (tisilfocon A) Red

FDA UDI

Class III (US FDA UDI)

by Menicon Co., Ltd.

Identity

Trade Name
MeniconZ (tisilfocon A) Red FDA UDI
Generic Name
Orthokeratology contact lens FDA UDI
Model / Reference
Wine Red FDA UDI

Identifiers

Primary DI / UDI-DI
00192538901086 FDA UDI
FDA Product Code
MWL FDA UDI
NUU FDA UDI
GMDN Term
Orthokeratology contact lens FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
886.5916 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthokeratology contact lensRigid-gas-permeable corrective contact lens, extended-wear

MeniconZ (tisilfocon A) Red by Menicon Co., Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid-gas-permeable corrective contact lens, extended-wear.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Menicon Co., Ltd.

Sources (1)

  • FDA UDI 440dab8b-fe85-4301-8cad-32a4fd85ac99 32 fields · synced May 31, 2026