Identity
- Trade Name
- ArtiSential Graspers EUDAMED
- Device Name
- Laparoscopic Instruments - Graspers EUDAMED
- Model / Reference
- AUD01S-FV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042701086 EUDAMED
- Basic UDI-DI
- 88000427GraspersJ8 EUDAMED
- EMDN Code
- K01020101 MINIMALLY INVASIVE SURGERY DISSECTORS, SINGLE-USE 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
ArtiSential Graspers by LivsMed 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 | 88000427GraspersJ8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LivsMed Inc.
- EUDAMED SRN
- KR-MF-000011855
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED 0ed7b1c8-68f0-4dca-a997-abcaeec04adc 61 fields · synced Jun 19, 2026