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Cruiser
EUDAMEDFDA UDIClass I (EU MDR)
Ref 904851Model SeatingRef 904855Ref 903314
Identity
- Trade Name
- Cruiser EUDAMEDConvaid FDA UDI
- Generic Name
- Attendant-only-propelled wheelchair, non-bariatric FDA UDI
- Model / Reference
- Seating EUDAMED904851 EUDAMED904855 EUDAMED903314 EUDAMEDCruiser 10 FDA UDICruiser 18 Transit FDA UDI
Identifiers
- Catalog Number
- 903314 FDA UDI904855 FDA UDI
- Primary DI / UDI-DI
- 00840117408012 EUDAMED00840117408159 EUDAMED00840117408005 EUDAMED10840117401959 FDA UDI10840117405759 FDA UDI
- Basic UDI-DI
- 08401174SEATINGMWCVC EUDAMED
- 510(k) Number
- K810676 FDA UDI
- FDA Product Code
- LBE 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
- 890.3850 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cruiser 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 (5)
- EUDAMED 0fdf67ac-e9e7-4cb2-ac00-e96c87b5a1c7 61 fields · synced Jul 12, 2026
- EUDAMED a364c947-5596-41df-9bd1-fe4d3f533d4d 61 fields · synced May 18, 2026
- FDA UDI 5ca42fe7-1b87-44fd-a2a5-e55ee42ccec8 34 fields · synced May 30, 2026
- FDA UDI 20bb0450-ce44-4ade-a14a-7ad0d1898acc 34 fields · synced May 30, 2026
- EUDAMED 27453016-bff3-4d5a-9f25-cc8eb59d58ad 61 fields · synced Jul 12, 2026