← Back to catalogue
Intimate Rose Rectal Dilator pack of 8
EUDAMEDClass I (EU MDR)
Ref Rectal Dilator Pack of 8Model Intimate Rose Rectal Dilator pack of 8
Identity
- Device Name
- Intimate Rose Rectal Dilator pack of 8 EUDAMED
- Model / Reference
- Intimate Rose Rectal Dilator pack of 8 EUDAMEDRectal Dilator Pack of 8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850005838616 EUDAMED
- Basic UDI-DI
- 0850005838IR-036M9 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 Rectal Dilator pack of 8 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-036M9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Plus EV Holdings
- EUDAMED SRN
- US-MF-000046028
- Authorised Representative
- Global E-commerce Experts Europe BV NL-AR-000038301
Sources (1)
- EUDAMED b441521a-295d-42c0-9c2e-7daa6cfc4eb2 61 fields · synced Jul 8, 2026