Guidewire Impella
EUDAMEDFDA UDIClass IIa (EU MDR)
by Abiomed Inc.
Identity
- Trade Name
- Impella FDA UDI
- Generic Name
- Intracardiac circulatory assist axial-pump catheter FDA UDI
- Device Name
- Guidewire Impella EUDAMEDGuide Wire 0.018" PTFE coated FDA UDI
- Model / Reference
- 0052-3005, 0052-3018 EUDAMED0052-3005/0052-3018 EUDAMED0052-3005 FDA UDI
- Description
- Guide Wire 0.018" PTFE coated FDA UDI
Identifiers
- Catalog Number
- 0052-3005 FDA UDI
- Primary DI / UDI-DI
- 04260113630303 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260113630303 EUDAMED
- FDA Product Code
- OZD FDA UDIDQX FDA UDI
- EMDN Code
- C0480 CARDIOVASCULAR GUIDEWIRES - ACCESSORIES EUDAMED
- GMDN Term
- Intracardiac circulatory assist axial-pump catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
Guidewire Impella by Abiomed, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260113630303 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Abiomed Inc.
- EUDAMED SRN
- US-MF-000016855
- Authorised Representative
- Abiomed Europe GmbH DE-AR-000005280
Sources (2)
- EUDAMED b50bad51-75d2-4e38-a50d-3c079c6cdbce 61 fields · synced Jun 19, 2026
- FDA UDI e3086f40-e290-4322-a9ea-d2cb91cdedef 34 fields · synced May 29, 2026