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Smilex Skin Flex
EUDAMEDClass I (EU MDR)
Ref GU151XLModel GUANTO IN VINILE Ref GU151L
Identity
- Trade Name
- SMILEX SKIN FLEX EUDAMED
- Device Name
- GUANTO MONOUSO IN VINILE SENZA POLVERE NON STERILE EUDAMED
- Model / Reference
- GUANTO IN VINILE EUDAMEDGU151XL EUDAMEDGU151L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08024151812475 EUDAMED08024151812468 EUDAMED
- Basic UDI-DI
- 8024151GUVSZQ EUDAMED
- Direct Marketing DI
- 08024151812475 EUDAMED08024151812468 EUDAMED
- EMDN Code
- T01020201 VINYL 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
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
Smilex Skin Flex 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 | 8024151GUVSZQ | Class I | Active |
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Manufacturer
- Manufacturer
- Bericah S.p.A.
- EUDAMED SRN
- IT-MF-000007397
Sources (2)
- EUDAMED ea470af4-a70e-4c63-87f7-d2c90f9d9ed6 61 fields · synced Jul 14, 2026
- EUDAMED ae0fdffd-202b-42ec-8bc5-feae646e73a9 61 fields · synced May 18, 2026