Identity
- Trade Name
- G-DENT EUDAMED
- Device Name
- G-Dent Prophylaxis Powder EUDAMED
- Model / Reference
- GDPP400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684181004082 EUDAMED
- Basic UDI-DI
- 8684181GDPP9D EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
G-Dent by Atlas-Enta Di̇şçi̇li̇k Sanayi̇ Ve Ti̇caret A.ş — 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 | 8684181GDPP9D | Class I | Active |
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Manufacturer
- Manufacturer
- Atlas-Enta Di̇şçi̇li̇k Sanayi̇ Ve Ti̇caret A.ş
- EUDAMED SRN
- TR-MF-000028947
Sources (1)
- EUDAMED 3dc27ffa-e19e-499b-be40-29f79bcc7b89 61 fields · synced Oct 6, 2026