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Intimate Rose Dilator 4Pack 5-8
EUDAMEDFDA UDIClass I (EU MDR)
Ref Dilators LargeModel Intimate Rose Dilator 4Pack 5-8
Identity
- Trade Name
- Intimate Rose FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- Intimate Rose Dilator 4Pack 5-8 EUDAMEDIntimate Rose Large 4Pack Dilators (5-8) FDA UDI
- Model / Reference
- Intimate Rose Dilator 4Pack 5-8 EUDAMEDDilators Large EUDAMEDIR-016 FDA UDI
- Description
- Intimate Rose Large 4Pack Dilators (5-8) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005838043 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850005838IR-016M3 EUDAMED
- FDA Product Code
- HDX FDA UDI
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
- GMDN Term
- Vaginal dilator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.3900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Intimate Rose Dilator 4Pack 5-8 by Plus EV Holdings — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850005838IR-016M3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED e48733e3-3dae-4779-bd84-55874a653c45 61 fields · synced Jun 19, 2026
- FDA UDI 07422e20-f8ca-42e3-8898-7bdd776a200f 34 fields · synced May 30, 2026