Identity
- Trade Name
- SENSILATEX EUDAMED
- Device Name
- GUANTO MONOUSO IN LATTICE SENZA POLVERE NON STERILE EUDAMED
- Model / Reference
- LATEX GLOVE EUDAMED42578 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08024151425781 EUDAMED
- Basic UDI-DI
- 8024151GULSYS EUDAMED
- Direct Marketing DI
- 08024151425781 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sensilatex by Bericah S.p.A. — 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 | 8024151GULSYS | Class I | Active |
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Manufacturer
- Manufacturer
- Bericah S.p.A.
- EUDAMED SRN
- IT-MF-000007397
Sources (1)
- EUDAMED 4b28fcc1-4216-422b-9e81-35292caf07d1 61 fields · synced Jun 18, 2026