Identity
- Trade Name
- Needle Holder (Not sterile) EUDAMED
- Device Name
- IMACTIS non sterile needle holder EUDAMED
- Model / Reference
- A10200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B681A102001 EUDAMED
- Basic UDI-DI
- ++B6813001NSTWS EUDAMED
- Direct Marketing DI
- +B681A102001 EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Needle Holder (Not sterile) by Imactis Sas — Class I — 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 | ++B6813001NSTWS | Class I | Active |
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Manufacturer
- Manufacturer
- Imactis Sas
- EUDAMED SRN
- FR-MF-000004452
Sources (1)
- EUDAMED f6c834f3-45a9-43d9-abbb-944807900a74 61 fields · synced Jun 18, 2026