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Connecting set for cannulas and Cannula extension set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A09-009mRef A06-009mRef A06-006
Identity
- Trade Name
- EXCOR® FDA UDI
- Generic Name
- External ventricular circulatory assist system FDA UDI
- Device Name
- Connecting set for cannulas and Cannula extension set EUDAMEDCannula extension set; Ø 6/6 mm FDA UDI
- Model / Reference
- A09-009m EUDAMEDA06-009m EUDAMEDA06-006 EUDAMEDFDA UDI
- Description
- Cannula extension set; Ø 6/6 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260090042748 EUDAMED04260090042731 EUDAMED04260090040140 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260090042526QR EUDAMED
- FDA Product Code
- DSQ FDA UDI
- EMDN Code
- C03010499 EXTRACORPOREAL CIRCULATION CANNULAS - OTHER EUDAMED
- GMDN Term
- External ventricular circulatory assist system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 6 Millimeter FDA UDI
Connecting set for cannulas and Cannula extension set by Berlin Heart GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 4260090042526QR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Berlin Heart GmbH
- EUDAMED SRN
- DE-MF-000006521
Sources (4)
- EUDAMED 9b6d8e79-0f92-41c5-ae26-0c2ab4078e1c 61 fields · synced Jul 23, 2026
- EUDAMED c7b4e733-0438-461c-ab2a-990d1abbec83 61 fields · synced May 17, 2026
- EUDAMED 6c1d65ba-c4d8-40c6-b261-299f8ae3f01b 61 fields · synced May 17, 2026
- FDA UDI 3a3b6ce8-a048-4839-ab9c-ca4143f94d3b 37 fields · synced May 30, 2026