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ArtiSential Needle Holder
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ANH01S-LV
by LivsMed Inc.
Identity
- Trade Name
- ArtiSential Needle Holder EUDAMEDFDA UDI
- Generic Name
- Suturing needle holder, single-use FDA UDI
- Device Name
- Laparoscopic Instruments – Needle Holders EUDAMEDSterile Single-use Manual Surgical Instrument for general use. FDA UDI
- Model / Reference
- ANH01S-LV EUDAMEDFDA UDI
- Description
- Sterile Single-use Manual Surgical Instrument for general use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800042701260 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000427NeedleHolder77 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- K01020105 MINIMALLY INVASIVE SURGERY NEEDLE HOLDERS, SINGLE-USE EUDAMED
- GMDN Term
- Suturing needle holder, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Shaft Length — 25 Centimeter FDA UDI
ArtiSential Needle Holder by LivsMed Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000427NeedleHolder77 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 a6f9d879-88ac-4625-8227-6c186af35873 61 fields · synced Jul 9, 2026
- FDA UDI 00bf4e11-1fb6-4f89-a39f-a25b98e17645 36 fields · synced May 30, 2026