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Speculum Monouso Sterile Chiusura A Perno Grande
EUDAMEDClass I (EU MDR)
Ref 0814
Identity
- Trade Name
- SPECULUM MONOUSO STERILE CHIUSURA A PERNO GRANDE EUDAMED
- Device Name
- SPECULUM MONOUSO STERILE CHIUSURA A VITE EUDAMED
- Model / Reference
- 0814 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055510561000 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 Perno 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 78309056-540f-4e09-94d7-d9a84e905848 61 fields · synced Aug 1, 2026