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Needle Holder
EUDAMEDClass I (EU MDR)
Ref A10010Model IMACTIS sterile needle holder
by Imactis Sas
Identity
- Trade Name
- Needle Holder EUDAMED
- Device Name
- IMACTIS sterile needle holder EUDAMED
- Model / Reference
- IMACTIS sterile needle holder EUDAMEDA10010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B681A100101 EUDAMED
- Basic UDI-DI
- ++B6813001STEWQ EUDAMED
- Direct Marketing DI
- +B681A100101 EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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 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 | ++B6813001STEWQ | Class I | Active |
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Manufacturer
- Manufacturer
- Imactis Sas
- EUDAMED SRN
- FR-MF-000004452
Sources (1)
- EUDAMED 378c8d74-6994-43ee-b74f-f34b86747a91 61 fields · synced Jul 10, 2026