Identity
- Trade Name
- Incontinence Probe EUDAMED
- Device Name
- Incontinence Probe EUDAMED
- Model / Reference
- PE0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944414043946 EUDAMED
- Basic UDI-DI
- 69444140012SK EUDAMED
- EMDN Code
- U0780 DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Incontinence Probe by Shenzhen Med-link Electronics Tech Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210441 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69444140012SK | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Med-link Electronics Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011145
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f4f6ffdb-50d8-46fc-9bed-ecdd54df5123 61 fields · synced Jul 21, 2026
- FDA 510(k) K210441 1 fields · synced May 18, 2026