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Impella Purge Cassette
EUDAMEDClass IIa (EU MDR)
Ref 0043-0002, 0043-0003Model 0043-0001, 0043-0009Ref 0043-0001
by Abiomed Inc.
Identity
- Trade Name
- Impella Purge Cassette EUDAMED
- Device Name
- Impella Purge Cassette EUDAMED
- Model / Reference
- 0043-0001, 0043-0009 EUDAMED0043-0002, 0043-0003 EUDAMED0043-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813502011999 EUDAMED
- Basic UDI-DI
- B-00813502011999 EUDAMED081350201199200201QZ EUDAMED
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDA030199 CONTROLLERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Impella Purge Cassette by Abiomed, Inc. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00813502011999 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00813502011999 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Abiomed Inc.
- EUDAMED SRN
- US-MF-000016855
- Authorised Representative
- Abiomed Europe GmbH DE-AR-000005280
Sources (3)
- EUDAMED 9aa24528-fcf3-4d90-88e5-1de6b5859f8d 61 fields · synced Jul 17, 2026
- EUDAMED b664977f-ec8f-477a-98c4-b19578de9e13 61 fields · synced May 17, 2026
- EUDAMED 9aa24528-fcf3-4d90-88e5-1de6b5859f8d-1 61 fields · synced Jun 10, 2026