Identity
- Trade Name
- I-Sil Regular Body Jumbo EUDAMED
- Device Name
- i-Sil Regular Body EUDAMED
- Model / Reference
- #7205PJU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809262958041 EUDAMED
- Basic UDI-DI
- 880926295RB2R EUDAMED
- Direct Marketing DI
- 08809262958041 EUDAMED
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
I-Sil Regular Body Jumbo by Spident — Class I — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880926295RB2R | Class I | Active |
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Manufacturer
- Manufacturer
- Spident
- EUDAMED SRN
- KR-MF-000008691
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 2ae900a3-c32a-4e04-ace8-acf64b7f64ff 61 fields · synced May 23, 2026