Identity
- Trade Name
- AMALGAM INSTRUMENTS EUDAMED
- Device Name
- AMALGAM INSTRUMENTS EUDAMED
- Model / Reference
- FHQ-1580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G438FHQ15800 EUDAMED
- Basic UDI-DI
- ++G438FHQ1580PZ EUDAMED
- EMDN Code
- Q010505 AMALGAM APPLICATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 FHQ Trading CO. — 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 | ++G438FHQ1580PZ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FHQ Trading CO.
- EUDAMED SRN
- PK-MF-000033179
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 0d7ac75e-890f-454a-97f2-046ecb1cf72f 61 fields · synced Jul 18, 2026