Identity
- Trade Name
- 194.13XL modeling instr. n2 EUDAMED
- Device Name
- Amalgam instruments EUDAMED
- Model / Reference
- 194.13XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03665224025535 EUDAMED
- Basic UDI-DI
- 3665224AMALGAMINSTR3J EUDAMED
- Direct Marketing DI
- 03665224025535 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER 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
194.13XL modeling instr. n2 by Prodont-Holliger — 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 | 3665224AMALGAMINSTR3J | Class I | Active |
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Manufacturer
- Manufacturer
- Prodont-Holliger
- EUDAMED SRN
- FR-MF-000000956
Sources (1)
- EUDAMED b8fb5921-a093-4d31-8005-479e3ba1c3d0 61 fields · synced Jun 17, 2026