Identity
- Trade Name
- LeMaitre Valvulotome EUDAMED
- Device Name
- LeMaitre® Valvulotome EUDAMED
- Model / Reference
- 1009-00M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840663111169 EUDAMED
- Basic UDI-DI
- 08406631LMATVtomAV EUDAMED
- EMDN Code
- C019017 VALVULOTOMES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
LeMaitre Valvulotome 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 | 08406631LMATVtomAV | Class IIa | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
- EUDAMED SRN
- US-MF-000016778
- Authorised Representative
- LeMaitre Vascular GmbH DE-AR-000013539
Sources (1)
- EUDAMED d5cc11eb-6f32-4e3c-b2d4-939f148a619d 61 fields · synced Jun 9, 2026