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Penumbra ENGINE Pump
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PMXENGNModel Aspiration Pump
Identity
- Trade Name
- Penumbra ENGINE Pump EUDAMEDPenumbra System FDA UDI
- Generic Name
- Suction/irrigation tubing, single-use FDA UDI
- Device Name
- Penumbra ENGINE Pump EUDAMEDPenumbra ENGINE FDA UDI
- Model / Reference
- Aspiration Pump EUDAMEDPMXENGN EUDAMEDFDA UDI
- Description
- Penumbra ENGINE FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-PenumbraAPumpsN3 EUDAMED00815948020030 FDA UDI
- Basic UDI-DI
- B-PenumbraAPumpsN3 EUDAMED
- 510(k) Number
- K180008 FDA UDI
- FDA Product Code
- NRY FDA UDI
- EMDN Code
- A060199 SURGICAL DRAINAGE SYSTEMS - OTHER EUDAMED
- GMDN Term
- Suction/irrigation tubing, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 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
Yes
EUDAMED
Contains Latex
Yes
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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Penumbra ENGINE Pump by Penumbra, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-PenumbraAPumpsN3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
- EUDAMED SRN
- US-MF-000008514
- Authorised Representative
- Penumbra Europe GmbH DE-AR-000004997
Sources (2)
- EUDAMED bbf14479-6099-4b4c-a601-2bd6100b5df9 61 fields · synced May 31, 2026
- FDA UDI 0db6e18d-c643-4049-9a1d-6adbf9a01d65 34 fields · synced May 30, 2026