Identity
- Trade Name
- Vaginal speculums for single use EUDAMED
- Device Name
- Vaginal speculums for single use EUDAMED
- Model / Reference
- T133782 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970654586936 EUDAMED
- Basic UDI-DI
- 697065458MD3115DA EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Vaginal speculums for single use by Jiangsu Rongye Technology 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 | 697065458MD3115DA | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Rongye Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019627
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 82915ca0-f1ce-409d-bd5d-aee10407ce66 61 fields · synced Jul 8, 2026