Identity
- Trade Name
- Concerto EUDAMEDFDA UDI
- Generic Name
- Bathing/changing table, mobile FDA UDI
- Device Name
- CONCERTO EUDAMEDCONCERTO SHOWER TROLLEY, 1600MM HYDRAULIC FDA UDI
- Model / Reference
- BAB5000-01 EUDAMEDBAB2000-01 EUDAMEDFDA UDI
- Description
- CONCERTO SHOWER TROLLEY, 1600MM HYDRAULIC FDA UDI
Identifiers
- Catalog Number
- BAB2000-01 FDA UDI
- Primary DI / UDI-DI
- 05055982788106 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
Concerto 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.
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- MCT 5 change trolley, 700 x 1700 mm, two fold-down sides, white. Manually height adjustable with foot pedal — Pressalit A/S · Class I
- Mobi Changer Size 2 - Mild Steel — SMIRTHWAITE LTD · Class I
- Easi-Lift Shower Stretcher without headrest - Size 4 — SMIRTHWAITE LTD · Class I
- MCT 5 change trolley, 700 x 2100 mm, two fold-down sides, white. Manually height adjustable with foot pedal — Pressalit A/S · Class I
- SCT 1000 shower change table, lying surface 600 x 1400 mm, with safety rail, foldable, white. Fixed height, wall-mounted — Pressalit A/S · 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 | 5060693520273WC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED d456927b-1c53-49e4-9b60-f6bcf4208372 61 fields · synced Sep 18, 2026
- FDA UDI 883431b6-b4aa-47e2-8088-7b2d7731bdb7 35 fields · synced May 30, 2026