Identity
- Trade Name
- SPRINTER CART XL EUDAMEDNA FDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Device Name
- SPRINTER CART XL EUDAMED
- Model / Reference
- 701054184 EUDAMEDSPRINTER CART XL FDA UDI
Identifiers
- Catalog Number
- 70105.4184 FDA UDI
- Primary DI / UDI-DI
- 04037691746289 EUDAMEDFDA UDI
- Basic UDI-DI
- 405886374628FB EUDAMED
- Direct Marketing DI
- 04037691746289 EUDAMED
- FDA Product Code
- KRI FDA UDI
- EMDN Code
- Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromechanical device/system transport trolley FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.4200 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Dimensions & Sizes
- Size
- Depth — 840 Millimeter FDA UDIHeight — 1116 Millimeter FDA UDIWidth — 628 Millimeter FDA UDI
Sprinter Cart Xl by Maquet Cardiopulmonary GmbH — 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 | 405886374628FB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (2)
- EUDAMED c2e1545a-958a-4f54-9b23-0da27af5e450 61 fields · synced Jun 17, 2026
- FDA UDI ed27ca4c-f584-492c-a8ca-3a839f21a95d 35 fields · synced May 30, 2026