Cordless high performance LED headlight

FDA UDI

Class I (US FDA UDI)

by Spiggle & Theis Medizintechnik GmbH

Identity

Trade Name: Cordless high performance LED headlight FDA UDI
Generic Name: Head-worn fibreoptic light FDA UDI
Device Name: "HighLite" with comfortable headband transformer & charger, with mobile FDA UDI
Model / Reference: 10-122-00 FDA UDI
Description: "HighLite" with comfortable headband transformer & charger, with mobile FDA UDI

Identifiers

Catalog Number: 10-122-00 FDA UDI
Primary DI / UDI-DI: 04053755180318 FDA UDI
FDA Product Code: EBA FDA UDI
GMDN Term: Head-worn fibreoptic light 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Head-worn fibreoptic light

Cordless high performance LED headlight by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Head-worn fibreoptic light.

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105 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
BR Surgical, LLC — BR SURGICAL LLC · Class II
Surgical Headlight — GULF FIBEROPTICS, INC. · Class II

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: Spiggle & Theis Medizintechnik GmbH

Sources (1)

FDA UDI 3427c34c-2388-4a2d-8418-ccb3ffccba2d 35 fields · synced May 30, 2026