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Biofeedback and Stimulation System
EUDAMEDClass IIa (EU MDR)
Ref PR8Ref S2Ref PE4Ref P16Ref Q1105
Identity
- Trade Name
- Biofeedback and Stimulation System EUDAMED
- Device Name
- Biofeedback and Stimulation System EUDAMED
- Model / Reference
- PR8 EUDAMEDS2 EUDAMEDPE4 EUDAMEDP16 EUDAMEDQ1105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413816602 EUDAMED06944413821163 EUDAMED06944413812413 EUDAMED06944413812383 EUDAMED06944413821125 EUDAMED
- Basic UDI-DI
- 69444138PRS5W EUDAMED69444138S12SRA EUDAMED69444138PSFX EUDAMED69444138Q12SQU EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Biofeedback and Stimulation System by Edan Instruments, Inc. — Class IIa — 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 | 69444138PRS5W | Class IIa | 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 (5)
- EUDAMED 0cef1c8e-52df-47c3-8ec2-9cf1699a03d5 61 fields · synced Aug 4, 2026
- EUDAMED e1e2a678-16a3-45a1-bcad-73a670f38420 61 fields · synced Jul 16, 2026
- EUDAMED 01a7c4ef-a3f2-4835-9652-74257f458b00 61 fields · synced Jul 19, 2026
- EUDAMED 154ba14b-c23e-4af8-af7e-fa3f9aa3df0c 61 fields · synced Jul 29, 2026
- EUDAMED bb7068a4-ac77-458a-957d-8b64b06d8f56 61 fields · synced Aug 4, 2026