Identity
- Trade Name
- Carmina EUDAMEDFDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- CARMINA BASIC EUDAMEDCarmina, shower and commode chair with footrest and push bar FDA UDI
- Model / Reference
- BLB1000-013 EUDAMEDBLB2000-013 EUDAMEDFDA UDI
- Description
- Carmina, shower and commode chair with footrest and push bar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982786980 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520266WF EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y091203 CHAIRS, TOILET AND SHOWER EUDAMED
- GMDN Term
- Shower seat, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 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
Carmina by Arjohuntleigh AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5060693520266WF | 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 d1ab0b71-af23-4872-aefa-c7dfaa47b47a 61 fields · synced Jun 19, 2026
- FDA UDI f059084c-5cc0-4808-9a95-2432fa8fd1c2 33 fields · synced May 30, 2026