Identity
- Trade Name
- Coaster EUDAMEDConvaid FDA UDI
- Generic Name
- Attendant-only-propelled wheelchair, non-bariatric FDA UDI
- Model / Reference
- Seating EUDAMED800162 EUDAMEDCoaster 16 Transit FDA UDI
Identifiers
- Catalog Number
- 800162 FDA UDI
- Primary DI / UDI-DI
- 00840117408524 EUDAMED10840117400891 FDA UDI
- Basic UDI-DI
- 08401174SEATINGMWCVC EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
- GMDN Term
- Attendant-only-propelled wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Denmark 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
No
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
Coaster by Convaid Products LLC — 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 | 08401174SEATINGMWCVC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Convaid Products LLC
- EUDAMED SRN
- US-MF-000002416
- Authorised Representative
- R82 A/S DK-AR-000001289
Sources (2)
- EUDAMED 21cc387e-6871-4438-8482-e479e6466127 61 fields · synced Jul 11, 2026
- FDA UDI d9fd1c01-fe3e-4084-bf8d-fb7e6c3efb63 33 fields · synced May 29, 2026