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Showering and changing table 3000

FDA UDI

Class I (US FDA UDI)

by Pressalit A/S

Identity

Trade Name
Showering and changing table 3000 FDA UDI
Generic Name
Bathing/changing table, stationary FDA UDI
Device Name
Showering and changing table 3000, fixed height, 1300 mm, with safety rail and water collection tray, lead grey FDA UDI
Model / Reference
R8435313 FDA UDI
Description
Showering and changing table 3000, fixed height, 1300 mm, with safety rail and water collection tray, lead grey FDA UDI

Identifiers

Catalog Number
R8435313021 FDA UDI
Primary DI / UDI-DI
05708590357461 FDA UDI
FDA Product Code
INT FDA UDI
GMDN Term
Bathing/changing table, stationary FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3520 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: Bathing/changing table, stationary

Showering and changing table 3000 by Pressalit A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bathing/changing table, stationary.

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 add21463-a5cf-424f-af06-5940d8bdef92 35 fields · synced May 30, 2026