Identity
- Trade Name
- DuoSil EUDAMEDPEAK, PEAKOSIL EUDAMED
- Device Name
- Addition silicone impression materials EUDAMED
- Model / Reference
- DuoSil Light body EUDAMEDNONE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800156150121 EUDAMED
- Basic UDI-DI
- 880015615DU059P EUDAMEDB-08800156150121 EUDAMED
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS 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
Category: Silicone dental impression material
DuoSil by Bukwang Inc. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880015615DU059P | Class I | Active |
| EUDAMED | European Union | CE/MDR | 880015615DU059P | Class I | Active |
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Manufacturer
- Manufacturer
- Bukwang Inc.
- EUDAMED SRN
- KR-MF-000044591
- Authorised Representative
- SOAR & PARTNERS Sp. z o.o. PL-AR-000040956
Sources (2)
- EUDAMED 583da139-45af-459b-9a37-dd1c40e1dfbd 61 fields · synced Jul 30, 2026
- EUDAMED 6109abc9-c0a2-4bce-a8a9-e2c086329bef 61 fields · synced May 18, 2026