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Intimate Rose Kegel Weights
EUDAMEDFDA UDIClass I (EU MDR)
Ref Kegel Weights HB
Identity
- Trade Name
- Intimate Rose FDA UDI
- Generic Name
- Pelvic floor muscle exerciser FDA UDI
- Device Name
- Intimate Rose Kegel Weights EUDAMEDIntimate Rose Kegel Exercise System for pelvic floor weakness. Includes 6 silicone weights and instructions. FDA UDI
- Model / Reference
- Kegel Weights HB EUDAMEDIR-002 FDA UDI
- Description
- Intimate Rose Kegel Exercise System for pelvic floor weakness. Includes 6 silicone weights and instructions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005838135 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850005838IR-002LQ EUDAMED
- 510(k) Number
- K193364 FDA UDI
- FDA Product Code
- HIR FDA UDI
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
- GMDN Term
- Pelvic floor muscle exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1425 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
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 Kegel Weights 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-002LQ | 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 74e39636-b697-4596-9b8d-3af2bfab9abb 61 fields · synced Jul 10, 2026
- FDA UDI d824deac-90d1-4e94-a159-69b4ca2ee78f 35 fields · synced May 29, 2026