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Sensilatex
EUDAMEDClass I (EU MDR)
Ref 42577Model LATEX GLOVERef 42576Ref 42575
Identity
- Trade Name
- SENSILATEX EUDAMED
- Device Name
- GUANTO MONOUSO IN LATTICE SENZA POLVERE NON STERILE EUDAMED
- Model / Reference
- LATEX GLOVE EUDAMED42577 EUDAMED42576 EUDAMED42575 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08024151425774 EUDAMED08024151425767 EUDAMED08024151425750 EUDAMED
- Basic UDI-DI
- 8024151GULSYS EUDAMED
- Direct Marketing DI
- 08024151425774 EUDAMED08024151425767 EUDAMED08024151425750 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 (3)
- EUDAMED 0df2a110-b1ff-4cc6-9685-dfb48d578a41 61 fields · synced Jul 15, 2026
- EUDAMED b957fbc5-7a75-4701-8aff-f24a88a87309 61 fields · synced May 18, 2026
- EUDAMED 9dfbcd31-8e28-4ef8-ae69-f357ebd18859 61 fields · synced May 19, 2026