Smart Sil
by Seil Global South Korea EUDAMED
Ref SmartSil Heavy Body EMDN Q01020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88001564SEIL03J7 | Date1 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dental Impression Material
- Model / Reference
- SmartSil Heavy Body
- Primary DI / UDI-DI
- 08800156401612, 08800156401629
- Basic UDI-DI
- 88001564SEIL03J7
- EMDN Code
- Q01020102 Dental impression vinylsiloxans
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- KR-MF-000013925
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Seilglobal Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 1629ae57-7661-4122-8cd6-2aac0db42f19
- EUDAMED 08800156401629|88001564SEIL03J7