Identity
- Trade Name
- TAMPONE VAGINALE MAXI STERILE EUDAMED
- Device Name
- TAMPONI STERILI EUDAMED
- Model / Reference
- 2499 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055510560928 EUDAMED
- Basic UDI-DI
- 805551056tempone_sterMU EUDAMED
- EMDN Code
- M010103 COTTON PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Tampone Vaginale Maxi Sterile by Kaltek S.r.l. — 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 | 805551056tempone_sterMU | Class I | Active |
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Manufacturer
- Manufacturer
- Kaltek S.r.l.
- EUDAMED SRN
- IT-MF-000019573
Sources (1)
- EUDAMED bd0be003-1a50-421a-9202-295bdf6baaac 61 fields · synced Jul 25, 2026