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Vagina Dilator for Single Use
EUDAMEDClass I (EU MDR)
Ref ZDSModel Larg, Medium , Small
Identity
- Trade Name
- Vagina Dilator for Single Use EUDAMED
- Device Name
- Vagina Dilator for Single Use EUDAMED
- Model / Reference
- Larg, Medium , Small EUDAMEDZDS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756721041 EUDAMED
- Basic UDI-DI
- 69207567YDKZQ0001WZ EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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
Vagina Dilator for Single Use by Jiangxi Hongda Medical Equipment Group 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 | 69207567YDKZQ0001WZ | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangxi Hongda Medical Equipment Group Ltd.
- EUDAMED SRN
- CN-MF-000006019
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 680c4498-7fa6-419f-8489-703353cd118b 61 fields · synced Jun 19, 2026