Identity
- Trade Name
- VSXE One Refill pack EUDAMED
- Device Name
- Identium EUDAMED
- Model / Reference
- Identium EUDAMED14782 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E217147821 EUDAMED
- Basic UDI-DI
- ++E217IMPIDENTIUMFJ EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
VSXE One Refill pack by Kettenbach GmbH & Co. KG — Class IIa — 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 | ++E217IMPIDENTIUMFJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kettenbach GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005014
Sources (1)
- EUDAMED a35d734c-0b73-4bf9-8625-580af46f1043 61 fields · synced Jul 12, 2026