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Carevo

EUDAMEDFDA UDI

Class I (EU MDR)

Ref BAC1111-01Model BAB5000-01

by ArjoHuntleigh AB

Identity

Trade Name
Carevo EUDAMEDFDA UDI
Generic Name
Bathing/changing table, mobile FDA UDI
Device Name
CONCERTO EUDAMED
Carevo, - shower trolley with adjustable back support FDA UDI
Model / Reference
BAB5000-01 EUDAMED
BAC1111-01 EUDAMEDFDA UDI
Description
Carevo, - shower trolley with adjustable back support FDA UDI

Identifiers

Primary DI / UDI-DI
05055982787178 EUDAMEDFDA UDI
Basic UDI-DI
5060693520273WC EUDAMED
FDA Product Code
FSA FDA UDI
EMDN Code
Y093312 SHOWER STRETCHERS EUDAMED
GMDN Term
Bathing/changing table, mobile FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
880.5510 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bathing/changing table, mobile

Carevo by Arjohuntleigh AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bathing/changing table, mobile.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ArjoHuntleigh AB
EUDAMED SRN
SE-MF-000000696

Sources (2)

  • EUDAMED 78685cac-d736-4236-89cc-d40745bd1e14 61 fields · synced Jun 17, 2026
  • FDA UDI bc758d1e-3992-4764-9dca-a90bd06b7946 33 fields · synced May 29, 2026