Identity
- Device Name
- AMALGAM INSTRUMENTS EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 111822999612 EUDAMED
- Basic UDI-DI
- PP12633AMALGAMINST06 EUDAMED
- Direct Marketing DI
- 111822999612 EUDAMED
- EMDN Code
- Z12119002 AMALGAMATORS 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
Amalgam Instruments by Qureshi Manufacturing Corporation — 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 | PP12633AMALGAMINST06 | Class I | Active |
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Manufacturer
- Manufacturer
- Qureshi Manufacturing Corporation
- EUDAMED SRN
- PK-MF-000024744
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED a96c26f6-be51-4086-9599-19ce197d3941 61 fields · synced Jun 18, 2026