Identity
- Trade Name
- Amalgam Gun EUDAMED
- Device Name
- Amalgam Gun EUDAMED
- Model / Reference
- 400-024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003366858 EUDAMED
- Basic UDI-DI
- 8964003366SSIAG268027ZH EUDAMED
- EMDN Code
- L15901199 POSITIONING INSTRUMENTS FOR DENTAL DEVICES, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Gun by Shahab Surgical Industries — 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 | 8964003366SSIAG268027ZH | Class I | Active |
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Manufacturer
- Manufacturer
- Shahab Surgical Industries
- EUDAMED SRN
- PK-MF-000031219
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 0a37a80f-5000-44c8-ae38-4525e878bb2e 61 fields · synced Jun 19, 2026