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FDA UDI

Class I (US FDA UDI)

by Pressalit A/S

Identity

Trade Name
PLUS FDA UDI
Generic Name
Shower seat, power-adjusted FDA UDI
Device Name
PLUS shower seat 450, 17.7'' x 17.2'', incl. backrest and armrests, anthracite gray. Electrically height adjustable, wall-mounted FDA UDI
Model / Reference
R7834 FDA UDI
Description
PLUS shower seat 450, 17.7'' x 17.2'', incl. backrest and armrests, anthracite gray. Electrically height adjustable, wall-mounted FDA UDI

Identifiers

Catalog Number
R7834112 FDA UDI
Primary DI / UDI-DI
05708590374420 FDA UDI
FDA Product Code
INN FDA UDI
GMDN Term
Shower seat, power-adjusted FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Shower seat, power-adjusted

Plus by Pressalit A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shower seat, power-adjusted.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pressalit A/S

Sources (1)

  • FDA UDI 136e3da3-ee1e-4146-811b-57249b46bcaa 35 fields · synced May 30, 2026