Identity
- Trade Name
- Pruitt® Irrigation Occlusion Catheter EUDAMED
- Device Name
- Pruitt® Irrigation Occlusion Catheter EUDAMED
- Model / Reference
- 2102-09M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840663111343 EUDAMED
- Basic UDI-DI
- 08406631PIOCLH EUDAMED
- EMDN Code
- C0104020103 VASCULAR OCCLUSION CATHETERS 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
Yes
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
Pruitt® Irrigation Occlusion Catheter by LeMaitre Vascular, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08406631PIOCLH | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
- EUDAMED SRN
- US-MF-000016778
- Authorised Representative
- LeMaitre Vascular GmbH DE-AR-000013539
Sources (1)
- EUDAMED 4cec9d37-f8e9-4320-b3be-1eb55c1b8663 61 fields · synced Jul 9, 2026