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Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref KM-503/KM-504/KM-505/KM-506/KM-507/KM-5013/KM-502/KM-5018
Identity
- Trade Name
- Probe EUDAMEDKONMED FDA UDI
- Generic Name
- Perineal orifice incontinence-control electrical stimulation system probe, reusable FDA UDI
- Device Name
- Incontinence Stimulation Electrode EUDAMEDIncontinence probe Perineal orifice incontinence-control electrical stimulation system electrode FDA UDI
- Model / Reference
- KM-503/KM-504/KM-505/KM-506/KM-507/KM-5013/KM-502/KM-5018 EUDAMEDKM-503 FDA UDI
- Description
- Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970935830499 EUDAMEDFDA UDI
- Basic UDI-DI
- 697093583KM503K5 EUDAMED
- 510(k) Number
- K233576 FDA UDI
- FDA Product Code
- KPI FDA UDI
- EMDN Code
- U0780 DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES EUDAMED
- GMDN Term
- Perineal orifice incontinence-control electrical stimulation system probe, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5320 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
MR Unsafe FDA UDI
Probe by Shenzhen Konmed Technology Co., Ltd. — Class IIa — 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 | 697093583KM503K5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Konmed Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018375
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 694d3437-a4c1-4cf3-a57d-f4479880934e 61 fields · synced May 30, 2026
- FDA UDI 0855049b-2cdd-4dc4-99a1-fb37ac6454c5 34 fields · synced May 30, 2026