Identity
- Device Name
- ArgenZ GT 98x12 A1 EUDAMED
- Model / Reference
- 128458 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D8181284580D EUDAMED
- Basic UDI-DI
- ++D818ZIRCONIA03CD EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
ArgenZ GT 98x12 A1 by The Argen 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 | ++D818ZIRCONIA03CD | Class IIa | Active |
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Manufacturer
- Manufacturer
- The Argen Corporation
- EUDAMED SRN
- US-MF-000022069
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED b62f800f-a8ea-434e-bbde-fcd6f320ec88 61 fields · synced Sep 17, 2026