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Cardiohelp II Base Unit
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 701077135Ref 701047999Ref 701048012
Identity
- Trade Name
- Cardiohelp II Base Unit EUDAMEDCARDIOHELP Base Unit EUDAMEDCARDIOHELP-i EUDAMEDMAQUET CARDIOHELP FDA UDIMAQUET CARDIOHELP FDA UDI
- Generic Name
- Cardiopulmonary bypass system, roller type FDA UDI
- Device Name
- Cardiohelp II Base Unit EUDAMEDCardiohelp-i EUDAMEDFDA UDICARDIOHELP Base Unit EUDAMEDCardio Help Base Unit FDA UDI
- Model / Reference
- 701077135 EUDAMED701047999 EUDAMED701048012 EUDAMEDCARDIOHELP System FDA UDICARDIOHELP Base Unit FDA UDI
- Description
- Cardiohelp-i FDA UDICardio Help Base Unit FDA UDI
Identifiers
- Catalog Number
- 70104.8012 FDA UDI70104.7999 FDA UDI
- Primary DI / UDI-DI
- 04058863314747 EUDAMED04037691658384 EUDAMEDFDA UDI04037691658247 EUDAMEDFDA UDI
- Basic UDI-DI
- 405886331474D7 EUDAMEDB-04037691658247 EUDAMEDB-04037691658384 EUDAMED
- Direct Marketing DI
- 04058863314747 EUDAMED
- 510(k) Number
- K133598 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- EMDN Code
- Z12050201 EXTRA-CORPOREAL CIRCULATION SYSTEMS EUDAMED
- GMDN Term
- Cardiopulmonary bypass system, roller type FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4220 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDIFDA 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
Cardiohelp II Base Unit by Maquet Cardiopulmonary GmbH — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 405886331474D7 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 405886331474D7 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (6)
- EUDAMED a9a0d0e4-91ae-4b4b-b938-d7a92b955db0 61 fields · synced Oct 6, 2026
- FDA UDI f599346c-a521-4cad-b8d9-8f52bc9c9838 36 fields · synced May 30, 2026
- FDA UDI 5f7dcb1e-20f1-4d20-951b-0c573efc2c9e 36 fields · synced May 30, 2026
- EUDAMED d72b3f72-f0e2-4cff-bc3d-deea8b8af9cc 61 fields · synced Jun 20, 2026
- EUDAMED 361d530b-2129-4097-83b1-aa1e33db1775 61 fields · synced Jul 10, 2026
- EUDAMED b12e366e-7e70-4d23-8394-ce3c59995f7e 61 fields · synced Jul 21, 2026