Identity
- Trade Name
- Elvie Trainer EUDAMEDElvie FDA UDI
- Generic Name
- Pelvic floor muscle exerciser FDA UDI
- Device Name
- Elvie Trainer EUDAMEDKegel exercise tracker FDA UDI
- Model / Reference
- EL01-01 EUDAMEDEL01 - Celeste FDA UDI
- Description
- Kegel exercise tracker FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060442520004 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044252EL01-01J8 EUDAMED
- FDA Product Code
- KXQ 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
- 884.5960 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
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Elvie Trainer by Willow Innovations, Inc. — 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 | 506044252EL01-01J8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Willow Innovations, Inc.
- EUDAMED SRN
- US-MF-000050199
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 09089e92-4984-4114-8f91-8c8d351e5d7e 61 fields · synced Jul 17, 2026
- FDA UDI 4fbacc49-bd9a-4426-aced-c7ab29434277 33 fields · synced May 30, 2026