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Intimate Rose Rectal Dilator - Size 3
EUDAMEDFDA UDIClass I (EU MDR)
Ref Rectal Dilator - Size 3Model Intimate Rose Rectal Dilator - Size 3
Identity
- Trade Name
- Intimate Rose FDA UDI
- Generic Name
- Rectal dilator, reusable FDA UDI
- Device Name
- Intimate Rose Rectal Dilator - Size 3 EUDAMEDIntimate Rose Rectal Dilator Size 3 FDA UDI
- Model / Reference
- Intimate Rose Rectal Dilator - Size 3 EUDAMEDRectal Dilator - Size 3 EUDAMEDIR-035-3 FDA UDI
- Description
- Intimate Rose Rectal Dilator Size 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005838500 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850005838IR-035-3T9 EUDAMED
- FDA Product Code
- FFP FDA UDI
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
- GMDN Term
- Rectal dilator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5450 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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 Rectal Dilator - Size 3 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-035-3T9 | 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 b0bfd732-9580-4826-906f-cf17308e6472 61 fields · synced Jun 19, 2026
- FDA UDI 233ec094-7929-4062-9cac-de18217a034e 34 fields · synced May 27, 2026