Identity
- Trade Name
- CLS 20-535 EUDAMEDCapacitive Level Sensor FDA UDI
- Generic Name
- Cardiopulmonary bypass system, roller type FDA UDI
- Device Name
- CLS 20-535 EUDAMED
- Model / Reference
- 701010855 EUDAMED20-535 FDA UDI
Identifiers
- Catalog Number
- 701010855 FDA UDI
- Primary DI / UDI-DI
- 04037691253114 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04037691253114 EUDAMED
- 510(k) Number
- K943803 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- EMDN Code
- Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
A comprehensive medical device directory listing the CLS 20-535. This device is a Class IIb cardiac pacemaker designed for implantation in patients with certain types of heart conditions.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04037691253114 | 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 (3)
- EUDAMED c209d169-33ca-4b51-99f9-d5b1ab65f45d 61 fields · synced Oct 6, 2026
- FDA UDI bcbae021-1b5c-46c9-9f7f-28fb143dbc92 34 fields · synced May 29, 2026
- EUDAMED 533c7f76-61a6-486d-a587-77852735335a 61 fields · synced Jul 31, 2026