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Cardiosave Accessory Kit, IEC
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0020-00-0480-02Model Cardiosave
Identity
- Trade Name
- Cardiosave Accessory Kit, IEC EUDAMEDFDA UDI
- Generic Name
- Intra-aortic balloon pump FDA UDI
- Device Name
- Cardiosave EUDAMEDCARDIOSAVE Accessory Kit, IEC FDA UDI
- Model / Reference
- Cardiosave EUDAMED0020-00-0480-02 EUDAMEDFDA UDI
- Description
- CARDIOSAVE Accessory Kit, IEC FDA UDI
Identifiers
- Catalog Number
- 0020-00-0480-02 FDA UDI
- Primary DI / UDI-DI
- 10607567108551 EUDAMEDFDA UDI
- Basic UDI-DI
- 10607IABPaccessoriesBW EUDAMED
- FDA Product Code
- DSP FDA UDI
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Intra-aortic balloon pump FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.3535 FDA UDI
- Market of Registration
- Sweden 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cardiosave Accessory Kit, IEC by Datascope Corp. — 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 | 10607IABPaccessoriesBW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Datascope Corp
- EUDAMED SRN
- US-MF-000015587
- Authorised Representative
- MAQUET Critical Care AB SE-AR-000001442
Sources (2)
- EUDAMED fc06eaf2-6a50-4186-a554-414749de1651 61 fields · synced Jul 15, 2026
- FDA UDI d55afc08-f64b-46d8-9fc2-f6bf3f5f24bd 35 fields · synced May 30, 2026