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Sterile Vaginal Speculum for Single Use
EUDAMEDClass I (EU MDR)
Ref GV005Model GV001
Identity
- Trade Name
- Sterile Vaginal Speculum for Single Use EUDAMED
- Device Name
- Sterile Vaginal Speculum for Single Use EUDAMED
- Model / Reference
- GV001 EUDAMEDGV005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955053702309 EUDAMED
- Basic UDI-DI
- 695505370226GV001YW EUDAMED
- Direct Marketing DI
- 06955053702309 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Sterile Vaginal Speculum for Single Use by Vitaimed Instrument Co., Ltd. — 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 | 695505370226GV001YW | Class I | Active |
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Manufacturer
- Manufacturer
- Vitaimed Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000033172
- Authorised Representative
- VITAIMED GmbH DE-AR-000029575
Sources (1)
- EUDAMED 9a458536-4451-455b-99a1-327daa0b135b 61 fields · synced Jun 18, 2026