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Speculum Monouso A Vite Large
EUDAMEDClass I (EU MDR)
Ref 9198Model SPECULUM MONOUSO NON STERILE
Identity
- Trade Name
- SPECULUM MONOUSO A VITE LARGE EUDAMED
- Device Name
- SPECULUM MONOUSO NON STERILE EUDAMED
- Model / Reference
- SPECULUM MONOUSO NON STERILE EUDAMED9198 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055510560812 EUDAMED
- Basic UDI-DI
- 805551056speculum87 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE 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
Speculum Monouso A Vite Large 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 | 805551056speculum87 | Class I | Active |
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Manufacturer
- Manufacturer
- Kaltek S.r.l.
- EUDAMED SRN
- IT-MF-000019573
Sources (1)
- EUDAMED 4bf1f3dd-227e-403c-b2d9-b35a72e7ae98 61 fields · synced Jul 12, 2026