Romet

FDA UDI

Class I (US FDA UDI)

by Fountain Head Marketing Inc

Identity

Trade Name: Romet FDA UDI
Generic Name: Voice amplification system FDA UDI
Device Name: After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the consequent removal of the vocal cords, one is no longer able to speak. This condition is due to the absence of vibrations which were previously produced by the vocal cords. To overcome this challenge, there is no solution other than to artificially produce these vibrations. The ROMET Electronic Larynx or Electrolarynx, produces such vibrations and permits the user to emit clear and very comprehensible vocal sounds. The ROMET Electronic Larynx Model R210 Kit Includes: Full 2 Year Warranty - Including Drop On Hard Surface or In Liquid External Pitch & Volume Controls Larger, Ergonomic On/Off Button Polished Aluminum Barrel 2- 9V Lithium Batteries and "Smart" Charger Lanyard FDA UDI
Model / Reference: R210 FDA UDI
Description: After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the consequent removal of the vocal cords, one is no longer able to speak. This condition is due to the absence of vibrations which were previously produced by the vocal cords. To overcome this challenge, there is no solution other than to artificially produce these vibrations. The ROMET Electronic Larynx or Electrolarynx, produces such vibrations and permits the user to emit clear and very comprehensible vocal sounds. The ROMET Electronic Larynx Model R210 Kit Includes: Full 2 Year Warranty - Including Drop On Hard Surface or In Liquid External Pitch & Volume Controls Larger, Ergonomic On/Off Button Polished Aluminum Barrel 2- 9V Lithium Batteries and "Smart" Charger Lanyard FDA UDI

Identifiers

Primary DI / UDI-DI: 00860009460515 FDA UDI
FDA Product Code: ESE FDA UDI
GMDN Term: Voice amplification system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.3375 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Voice amplification system

Romet by Fountain Head Marketing Inc — 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: Fountain Head Marketing Inc

Sources (1)

FDA UDI 9338665e-2154-41e6-9a2b-1815b93804a1 34 fields · synced Jun 8, 2026