Dolphin II Plus

FDA UDI

Class I (US FDA UDI)

by Meden Inmed Sp Z O O

Identity

Trade Name: Dolphin II Plus FDA UDI
Generic Name: Shower seat, non-powered FDA UDI
Device Name: The mobile Dolphin II Commode/shower chair is to be used exclusively for assistance during moving or performing daily routine activities of persons with physical impairment disabilities. The chair allows the operator to adjust both, height and tilt of the seat enabling the patient to remain in the fixed position for a long time. The device is intended for use in privet homes, hospitals, sanatoriums, nursing homes or any other care facilities. Patients can be moved only through horizontal flat surfaces, and one floor of the building. If you need to transport on flat inclined/tilted surfaces, an additional person is recommended to assist with patient care. FDA UDI
Model / Reference: 90564 FDA UDI
Description: The mobile Dolphin II Commode/shower chair is to be used exclusively for assistance during moving or performing daily routine activities of persons with physical impairment disabilities. The chair allows the operator to adjust both, height and tilt of the seat enabling the patient to remain in the fixed position for a long time. The device is intended for use in privet homes, hospitals, sanatoriums, nursing homes or any other care facilities. Patients can be moved only through horizontal flat surfaces, and one floor of the building. If you need to transport on flat inclined/tilted surfaces, an additional person is recommended to assist with patient care. FDA UDI

Identifiers

Catalog Number: 01-KPR-0108-001 FDA UDI
Primary DI / UDI-DI: 05903684806683 FDA UDI
FDA Product Code: FSA FDA UDI
ILS FDA UDI
GMDN Term: Shower seat, non-powered FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5510 FDA UDI
890.5050 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

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: Shower seat, non-powered

Dolphin II Plus by Meden Inmed Sp Z O O — 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: Meden Inmed Sp Z O O

Sources (1)

FDA UDI 5f1db23c-7a88-48ec-85c8-75c1301da905 34 fields · synced Jun 8, 2026