InHealth Technologies - Blom-Singer

FDA UDI

Class II (US FDA UDI)

by Freudenberg Medical, Llc

Identity

Trade Name: InHealth Technologies; Blom-Singer FDA UDI
Generic Name: Tracheoesophageal speech valve, non-indwelling FDA UDI
Model / Reference: LP16-008-IR FDA UDI

Identifiers

Primary DI / UDI-DI: 00813307010272 FDA UDI
FDA Product Code: EWL FDA UDI
GMDN Term: Tracheoesophageal speech valve, non-indwelling FDA UDI
Models / Variants: InHealth Technologies FDA UDI
Blom-Singer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3730 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Tracheoesophageal speech valve, non-indwelling

InHealth Technologies - Blom-Singer by Freudenberg Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

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Also classified as Tracheoesophageal speech valve, non-indwelling.

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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 II	Pending data

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Manufacturer

Manufacturer: Freudenberg Medical, Llc

Sources (1)

FDA UDI b922ba00-8566-49ab-abd3-760bb7b4822c 33 fields · synced Sep 18, 2026