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ArtiSential Clip Applier
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ACA01S-L
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
- ACA01S-L EUDAMEDFDA UDI
- Description
- Sterile Single-use surgical ligation clip applier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800042700898 EUDAMEDFDA UDI
- 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 — 25 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 (2)
- EUDAMED e33fce46-8abe-46dd-b58e-414bae345385 61 fields · synced Jul 25, 2026
- FDA UDI 80ffa121-f33d-4f13-898b-48a677f0b70e 36 fields · synced May 30, 2026