Identity
- Trade Name
- Needle Holder EUDAMED
- Device Name
- Needle Holder EUDAMED
- Model / Reference
- A-SI-5319 EUDAMEDA-SI-5318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004115134 EUDAMED08964004115400 EUDAMED
- Basic UDI-DI
- 8964004115AI0624NH3009QS EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Suturing needle holder, reusable
Needle Holder by Artified International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Suturing needle holder, reusable.
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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 | 8964004115AI0624NH3009QS | Class I | Active |
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Manufacturer
- Manufacturer
- Artified International
- EUDAMED SRN
- PK-MF-000031406
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (2)
- EUDAMED 1ac8294a-2abd-42c9-89f4-5f22c00f68eb 61 fields · synced Jul 26, 2026
- EUDAMED 40b7e539-898c-438c-842a-19a6e2d917c2 61 fields · synced May 18, 2026