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EMG/Stimulation sensor
EUDAMEDClass I (EU MDR)
Ref SK5050WF-FRef SK72156WF-RRef SK85WF-YRef SV1Ref SK2020WF-YRef SA1Ref SA2
Identity
- Trade Name
- EMG/Stimulation sensor EUDAMED
- Device Name
- EMG/Stimulation sensor EUDAMED
- Model / Reference
- SK5050WF-F EUDAMEDSK72156WF-R EUDAMEDSK85WF-Y EUDAMEDSV1 EUDAMEDSK2020WF-Y EUDAMEDSA1 EUDAMEDSA2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413834736 EUDAMED06944413834088 EUDAMED06944413820074 EUDAMED06944413813854 EUDAMED06944413834149 EUDAMED06944413821392 EUDAMED06944413821453 EUDAMED
- Basic UDI-DI
- 69444138SKS5Q EUDAMED69444138ESS4A EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
EMG/Stimulation sensor by Edan Instruments, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69444138SKS5Q | Class I | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (8)
- EUDAMED 570e97b4-de0e-4044-b9db-854459eed674 61 fields · synced Jul 20, 2026
- EUDAMED a0a8ccbc-e415-4332-bae1-0f296b1df985 61 fields · synced May 16, 2026
- EUDAMED b7ad0ba9-c2b9-475e-8c7b-99d6638f41d7 61 fields · synced May 17, 2026
- EUDAMED 24d920c1-a7b4-45e8-ab3a-8475ecbedf57 61 fields · synced May 17, 2026
- EUDAMED e3172117-24a8-4bd6-a858-c0fa99e44179 61 fields · synced May 18, 2026
- EUDAMED 15862601-a8c8-43fc-9016-a38740028b54 61 fields · synced Jul 9, 2026
- EUDAMED 450cb448-752d-4d1f-89b0-8c4b83bafeff 61 fields · synced Jul 15, 2026
- EUDAMED 3f34df33-294e-4cc3-882c-5a26081a6bc2 61 fields · synced Jul 20, 2026