Eighteeth

FDA UDI

Class I (US FDA UDI)

by Changzhou Sifary Medical Technology Co., Ltd.

Identity

Trade Name: Eighteeth FDA UDI
Generic Name: Head-worn lamp FDA UDI
Device Name: Clinically, Lux-SFT Surgical Headlight is worn on the doctor's head for the lighting of the parts for diagnosis and examination of patients. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel and not used in the oxygen-rich environment. FDA UDI
Model / Reference: Lux-SFT FDA UDI
Description: Clinically, Lux-SFT Surgical Headlight is worn on the doctor's head for the lighting of the parts for diagnosis and examination of patients. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel and not used in the oxygen-rich environment. FDA UDI

Identifiers

Catalog Number: 5080901 FDA UDI
Primary DI / UDI-DI: 06941877819231 FDA UDI
FDA Product Code: EBA FDA UDI
GMDN Term: Head-worn lamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4630 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Head-worn lamp

Eighteeth by Changzhou Sifary Medical Technology Co., 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: Changzhou Sifary Medical Technology Co., Ltd.

Sources (1)

FDA UDI c690ca7f-c4c9-4d33-96f5-4059c78d41c9 34 fields · synced Jun 6, 2026