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ArtiSential Trocar
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AT0810
by LivsMed Inc.
Identity
- Trade Name
- ArtiSential Trocar EUDAMED
- Device Name
- Sterile Single Use Trocar EUDAMED
- Model / Reference
- AT0810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042701833 EUDAMED
- Basic UDI-DI
- 88000427ATXXXXQP EUDAMED
- EMDN Code
- K01010103 OPTICAL TROCAR, 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 Trocar by LivsMed Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212500 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000427ATXXXXQP | 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 (2)
- EUDAMED abf72390-036f-41c8-9181-4c8665455ba8 61 fields · synced Aug 2, 2026
- FDA 510(k) K212500 1 fields · synced May 18, 2026