Emyo®

FDA UDI

Class II (US FDA UDI)

by Prometheus Group Of New Hampshire Limited, The

Identity

Trade Name: EMYO® FDA UDI
Generic Name: Psychophysiological biofeedback system FDA UDI
Device Name: EMYO®200 is a Dual Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation FDA UDI
Model / Reference: EMYO®200 FDA UDI
Description: EMYO®200 is a Dual Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation FDA UDI

Identifiers

Catalog Number: EM200 FDA UDI
Primary DI / UDI-DI: 00852423006448 FDA UDI
FDA Product Code: HCC FDA UDI
GMDN Term: Psychophysiological biofeedback system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5050 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Psychophysiological biofeedback system

Emyo® by Prometheus Group Of New Hampshire Limited, The — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Prometheus Group Of New Hampshire Limited, The

Sources (1)

FDA UDI 5e53db66-f97f-43e5-b223-f27eaed5009b 34 fields · synced May 31, 2026