PlasmaTYPHOON

FDA UDIEUDAMED

Class I (US FDA UDI)

by Plasmabiotics

Identity

Trade Name: PlasmaTYPHOON FDA UDI
Generic Name: Endoscope clean-storage system FDA UDI
Device Name: PlasmaTYPHOON - unit for fast drying of endoscope channels and active storage of endoscopes Voltage: 100-120 VAC Frequency: 50/60 Hz Electric plug: Type B (USA, CA, JP, MX) FDA UDI
Model / Reference: Typhoon-V2TD120 FDA UDI
Description: PlasmaTYPHOON - unit for fast drying of endoscope channels and active storage of endoscopes Voltage: 100-120 VAC Frequency: 50/60 Hz Electric plug: Type B (USA, CA, JP, MX) FDA UDI

Identifiers

Primary DI / UDI-DI: 03701354400115 FDA UDI
FDA Product Code: LXG FDA UDI
GMDN Term: Endoscope clean-storage system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 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

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 50 Centimeter FDA UDI
Width — 50 Centimeter FDA UDI
Height — 50 Centimeter FDA UDI

Category: Endoscope clean-storage system

PlasmaTYPHOON by Plasmabiotics — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Endoscope clean-storage system.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Plasmabiotics

Sources (2)

FDA UDI 3f576642-e5d3-438c-99d5-9cb862897a36 35 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 4, 2026