Identity
- Device Name
- Disposable vaginal speculum EUDAMED
- Model / Reference
- XXS EUDAMEDSY001-XXS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972903331007 EUDAMED
- Basic UDI-DI
- B-06972903331007 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable vaginal speculum by Yuhuan City Shengbo Mould Manufacturing Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972903331007 | Class I | Active |
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Manufacturer
- Manufacturer
- Yuhuan City Shengbo Mould Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000036867
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 28a08d7c-2162-4ec4-8709-d6153bc793b4 61 fields · synced Jun 18, 2026