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Intimate Rose Vaginal Dilators - 8 Pack
EUDAMEDClass I (EU MDR)
Ref Vaginal Dilators - 8 PackModel Intimate Rose Vaginal Dilators - 8 Pack
Identity
- Device Name
- Intimate Rose Vaginal Dilators - 8 Pack EUDAMED
- Model / Reference
- Intimate Rose Vaginal Dilators - 8 Pack EUDAMEDVaginal Dilators - 8 Pack EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850005838579 EUDAMED
- Basic UDI-DI
- 0850005838IR-013LV EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Intimate Rose Vaginal Dilators - 8 Pack by Plus EV Holdings — 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 | 0850005838IR-013LV | Class I | Active |
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Manufacturer
- Manufacturer
- Plus EV Holdings
- EUDAMED SRN
- US-MF-000046028
- Authorised Representative
- Global E-commerce Experts Europe BV NL-AR-000038301
Sources (1)
- EUDAMED 146545f5-b510-4e37-ad8b-83561bc64f94 61 fields · synced Jul 11, 2026