Identity
- Trade Name
- Powerresins Night Guard Resin 500g- Clear EUDAMED
- Device Name
- Powerresins Night Guard Resin EUDAMED
- Model / Reference
- PNG-03-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684508853287 EUDAMED
- Basic UDI-DI
- 8684508853PNGN3 EUDAMED
- Direct Marketing DI
- 08684508853287 EUDAMED
- EMDN Code
- Q0102050199 DENTISTRY RESINS - 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
Powerresins Night Guard Resin 500g- Clear by 3bfab Teknoloji Anonim Şirketi — 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 | 8684508853PNGN3 | Class I | Active |
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Manufacturer
- Manufacturer
- 3bfab Teknoloji Anonim Şirketi
- EUDAMED SRN
- TR-MF-000040768
Sources (1)
- EUDAMED 4a4f967b-4711-40f9-bad3-4746f8d15674 61 fields · synced Oct 6, 2026