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Speculum Monouso Sterile Chiusura A Vite Grande
EUDAMEDClass I (EU MDR)
Ref 0801
Identity
- Trade Name
- SPECULUM MONOUSO STERILE CHIUSURA A VITE GRANDE EUDAMED
- Device Name
- SPECULUM MONOUSO STERILE CHIUSURA A VITE EUDAMED
- Model / Reference
- 0801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055510560980 EUDAMED
- Basic UDI-DI
- 805551056speculum_ster45 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE 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
Speculum Monouso Sterile Chiusura A Vite Grande 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 | 805551056speculum_ster45 | Class I | Active |
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Manufacturer
- Manufacturer
- Kaltek S.r.l.
- EUDAMED SRN
- IT-MF-000019573
Sources (1)
- EUDAMED b24b57dd-25dd-4565-b3df-6f41a1b21685 61 fields · synced Oct 6, 2026