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ArtiSential Needle Holder
EUDAMEDClass IIa (EU MDR)
Ref ANH01S-FV
by LivsMed Inc.
Identity
- Trade Name
- ArtiSential Needle Holder EUDAMED
- Device Name
- Laparoscopic Instruments – Needle Holders EUDAMED
- Model / Reference
- ANH01S-FV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042701253 EUDAMED
- Basic UDI-DI
- 88000427NeedleHolder77 EUDAMED
- EMDN Code
- K01020105 MINIMALLY INVASIVE SURGERY NEEDLE HOLDERS, 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 Needle Holder 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 | 88000427NeedleHolder77 | 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 ac880f78-c0c8-49eb-bf1b-8f3725721ae7 61 fields · synced Jun 18, 2026