Identity
- Trade Name
- NEEDLE HOLDER H12 EUDAMED
- Device Name
- NEEDLE HOLDER EUDAMED
- Model / Reference
- 02-0084 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760305400185 EUDAMED
- Basic UDI-DI
- 37603054001NEEDLEHOLDERLN EUDAMED
- Direct Marketing DI
- 03760305400185 EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES 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
Category: Neurological stereotactic surgery system
Needle Holder H12 by Quantum Surgical SAS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 37603054001NEEDLEHOLDERLN | Class I | Active |
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Manufacturer
- Manufacturer
- Quantum Surgical SAS
- EUDAMED SRN
- FR-MF-000000600
Sources (2)
- EUDAMED 69299434-0524-4a1e-8e3b-d72714ca3a69 61 fields · synced Jul 10, 2026
- EUDAMED b3749670-6c46-4da8-b5a5-5cabdd9eb8ee 61 fields · synced Jul 10, 2026