Identity
- Trade Name
- Quatron EUDAMED
- Device Name
- Quatron EUDAMED
- Model / Reference
- Quatron 31G/34G EUDAMEDNQ-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582542160016 EUDAMED
- Basic UDI-DI
- 458254216001C5 EUDAMED
- EMDN Code
- A01010199 HYPODERMIC NEEDLES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Quatron by Asti Corporation — Class IIa — 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 | 458254216001C5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Asti Corporation
- EUDAMED SRN
- JP-MF-000007443
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 8373cd26-7111-4cd7-8283-2c8a87944a68 61 fields · synced Jul 19, 2026