Raze

EUDAMEDFDA UDI

Class I (EU MDR)

Ref Z444

by Raz Design Inc.

Identity

Trade Name: Raze EUDAMED
Raz FDA UDI
Generic Name: Commode, manual FDA UDI
Device Name: Washing, Bathing and Showering Devices - Other EUDAMED
The Raze is a versatile stationary shower commode chair that can be configured as a raised toilet seat, a transfer tub seat or as a shower bench. Its tool less / adjustable design makes it portable and easy to adapt for different bathroom environments. FDA UDI
The Raze is a versatile stationary shower commode chair that can be configured as a raised toilet seat, a transfer tub seat or as a shower bench. Its tool less / adjustable design makes it portable and easy to adapt for different bathroom environments. Note: This DI was entered in error due to a typo. Correct DI is 00628758004448 FDA UDI
Model / Reference: Z444 EUDAMED
Raze FDA UDI
Description: The Raze is a versatile stationary shower commode chair that can be configured as a raised toilet seat, a transfer tub seat or as a shower bench. Its tool less / adjustable design makes it portable and easy to adapt for different bathroom environments. FDA UDI
The Raze is a versatile stationary shower commode chair that can be configured as a raised toilet seat, a transfer tub seat or as a shower bench. Its tool less / adjustable design makes it portable and easy to adapt for different bathroom environments. Note: This DI was entered in error due to a typo. Correct DI is 00628758004448 FDA UDI

Identifiers

Catalog Number: Z444 FDA UDI
Primary DI / UDI-DI: 00628758004448 EUDAMEDFDA UDI
00062875800444 FDA UDI
Basic UDI-DI: 628758RAZDESIGNINC2004V9 EUDAMED
FDA Product Code: INN FDA UDI
EMDN Code: Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
GMDN Term: Commode, manual FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 890.3100 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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: Hydrotherapy bath/tank

Raze by Raz Design Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Also classified as Hydrotherapy bath/tank.

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Primo — Arjohuntleigh, Inc. · Class II
Haltegriff Edelstahl, 40 cm — Ludwig Bertram GmbH · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	628758RAZDESIGNINC2004V9	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Raz Design Inc.
EUDAMED SRN: CA-MF-000004895
Authorised Representative: Advena Limited MT-AR-000000234

Sources (3)

EUDAMED d14e1ac9-6daa-4e47-aeac-ffa76325bd7c 61 fields · synced Jun 19, 2026
FDA UDI 02b47988-bcde-4519-a76f-2cd86138d0e2 34 fields · synced May 30, 2026
FDA UDI da2ba8d7-540f-4c68-a6db-10b636a3b241 36 fields · synced May 30, 2026