IwavePhoropter

FDA UDI

Class I (US FDA UDI)

by Krypton Vision (Suzhou) Ltd.

Identity

Trade Name: IwavePhoropter FDA UDI
Generic Name: Phoropter FDA UDI
Model / Reference: IwavePhoropter FDA UDI

Identifiers

Primary DI / UDI-DI: 06971053610017 FDA UDI
FDA Product Code: HKN FDA UDI
HKO FDA UDI
GMDN Term: Phoropter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1770 FDA UDI
886.1760 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

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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Phoropter

IwavePhoropter by Krypton Vision (Suzhou) Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Krypton Vision (Suzhou) Ltd.

Sources (1)

FDA UDI 78ffb60d-ff50-410a-b014-bbbb31983819 32 fields · synced May 30, 2026