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Temperature Therapy Pelvic Wand XSD
EUDAMEDFDA UDIClass I (EU MDR)
Ref Yellow WandModel Temperature Therapy Pelvic Wand XSD
Identity
- Trade Name
- Intimate Rose FDA UDI
- Generic Name
- Pelvic floor internal manual massager FDA UDI
- Device Name
- Temperature Therapy Pelvic Wand XSD EUDAMEDIntimate Rose Pelvic Wand - Temperature FDA UDI
- Model / Reference
- Temperature Therapy Pelvic Wand XSD EUDAMEDYellow Wand EUDAMEDIR-025 FDA UDI
- Description
- Intimate Rose Pelvic Wand - Temperature FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005838395 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850005838IR-025M4 EUDAMED
- FDA Product Code
- KXQ FDA UDI
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
- GMDN Term
- Pelvic floor internal manual massager FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.5960 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
No
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
Temperature Therapy Pelvic Wand XSD 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-025M4 | 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 110b8f12-8c18-4199-89d5-3fdbc78e85b5 61 fields · synced Jun 17, 2026
- FDA UDI 2fa790fb-3fdd-4061-82ce-e23c719c4dda 34 fields · synced May 30, 2026