Identity
- Trade Name
- Disposable Vaginal Speculum EUDAMED
- Device Name
- Disposable Vaginal Speculum EUDAMED
- Model / Reference
- 0506-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949717003185 EUDAMED
- Basic UDI-DI
- 69497170DVD1023R9 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
Disposable Vaginal Speculum by Ningbo HLS Medical Products 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 | 69497170DVD1023R9 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo HLS Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000026849
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED b4be1184-2ceb-437b-a016-89340ed29bb7 61 fields · synced Jun 19, 2026