Mobile Whirlpool 398l (105 Gal) - 120v

FDA UDI

Class II (US FDA UDI)

by Ortotecsa Sl

Identity

Trade Name: MOBILE WHIRLPOOL 398L (105 GAL) - 120V FDA UDI
Generic Name: Hydrotherapy bath/tank FDA UDI
Model / Reference: G.18951/400 (120V) FDA UDI

Identifiers

Primary DI / UDI-DI: 08436602170247 FDA UDI
FDA Product Code: ILJ FDA UDI
GMDN Term: Hydrotherapy bath/tank FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5100 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hydrotherapy bath/tank

Mobile Whirlpool 398l (105 Gal) - 120v by Ortotecsa Sl — 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: Ortotecsa Sl

Sources (1)

FDA UDI 015c1ad4-1c7a-4fd4-97e7-7004e5627aba 32 fields · synced May 30, 2026