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ArtiSential Clip Applier
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ACA01-LRef ACA01S-FVRef 8ACA01-LVRef 8ACA01-FVRef ACA01L-LRef ACA01-FVRef 5ACA01-FVRef ACA01-F
by LivsMed Inc.
Identity
- Trade Name
- ArtiSential Clip Applier EUDAMEDFDA UDI
- Generic Name
- Endoscopic surgical ligation clip applier, single-use FDA UDI
- Device Name
- Laparoscopic Instruments – Clip Appliers EUDAMEDSterile Single-use surgical ligation clip applier FDA UDI
- Model / Reference
- ACA01-L EUDAMEDFDA UDIACA01S-FV EUDAMED8ACA01-LV EUDAMED8ACA01-FV EUDAMEDACA01L-L EUDAMEDACA01-FV EUDAMED5ACA01-FV EUDAMEDACA01-F EUDAMED
- Description
- Sterile Single-use surgical ligation clip applier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800042700058 EUDAMEDFDA UDI08800042701376 EUDAMED08800042702915 EUDAMED08800042702922 EUDAMED08800042700911 EUDAMED08800042701369 EUDAMED08800042702885 EUDAMED08800042700065 EUDAMED
- Basic UDI-DI
- 88000427ClipApplierKM EUDAMED
- FDA Product Code
- GDO FDA UDI
- EMDN Code
- H020303 CLIP APPLIERS EUDAMED
- GMDN Term
- Endoscopic surgical ligation clip applier, 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 — 38 Centimeter FDA UDI
ArtiSential Clip Applier 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 | 88000427ClipApplierKM | 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 (9)
- EUDAMED c7409403-1d1c-4cd7-9ebc-fbce8a3580ef 61 fields · synced Jul 24, 2026
- EUDAMED 8ddfb001-09d9-4e1e-9eb6-9d3816a6a163 61 fields · synced May 16, 2026
- EUDAMED 056fb019-33ce-4ff6-b97f-31f9b932d88e 61 fields · synced May 17, 2026
- EUDAMED 5221b974-9bef-4d62-b44c-2e77913a9aa4 61 fields · synced May 17, 2026
- EUDAMED 5cb05a6d-c573-4267-8608-92839fc4f0dc 61 fields · synced May 18, 2026
- EUDAMED c7338dad-82a2-4932-8276-a795ac41ff7f 61 fields · synced May 18, 2026
- EUDAMED eec2406b-b7af-48bd-98f2-83e9e12d3a33 61 fields · synced May 18, 2026
- EUDAMED f8ac4185-9572-4ea8-9abc-0cfc613b582b 61 fields · synced May 19, 2026
- FDA UDI 39f19566-b210-4098-9e31-9e8df475d6d4 36 fields · synced May 30, 2026