Identity
- Trade Name
- Amalgam Instruments 15,5cm Medium 2 mm EUDAMED
- Device Name
- DENTAL DEVICES - VARIOUS EUDAMED
- Model / Reference
- R-016-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+B974R016150Q* EUDAMED
- Basic UDI-DI
- ++B974AmalgamXL EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES 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 15, 5cm Medium 2 mm by Dr.frigz International(pvt)ltd, — 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 | ++B974AmalgamXL | Class I | Active |
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Manufacturer
- Manufacturer
- Dr. Frigz International (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000009661
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED a31ba167-e734-4722-afd9-8de419e9de8d 61 fields · synced Oct 6, 2026