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Biofeedback and Stimulation System
EUDAMEDClass IIa (EU MDR)
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Identity
- Trade Name
- Biofeedback and Stimulation System EUDAMED
- Device Name
- Biofeedback and Stimulation System EUDAMED
- Model / Reference
- P4 EUDAMEDS12 EUDAMEDQ12 EUDAMEDPR4 Pro EUDAMEDPR40 EUDAMEDPA35 EUDAMEDQ12 Pro EUDAMEDQ10 EUDAMEDQ9 EUDAMEDPR35 EUDAMEDPA40 EUDAMEDQ8 EUDAMEDPR38 EUDAMEDS12 Pro EUDAMEDS10 Pro EUDAMEDS5 EUDAMEDQ5 EUDAMEDPR39 EUDAMEDPR36 EUDAMEDPA38 EUDAMEDPE16 EUDAMEDQ10 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413811928 EUDAMED06944413821231 EUDAMED06944413821095 EUDAMED06944413816589 EUDAMED06944413816619 EUDAMED06944413816541 EUDAMED06944413821118 EUDAMED06944413821088 EUDAMED06944413821071 EUDAMED06944413816671 EUDAMED06944413816503 EUDAMED06944413821064 EUDAMED06944413816688 EUDAMED06944413821255 EUDAMED06944413821248 EUDAMED06944413821187 EUDAMED06944413821040 EUDAMED06944413816565 EUDAMED06944413816640 EUDAMED06944413816527 EUDAMED06944413812406 EUDAMED06944413821101 EUDAMED
- Basic UDI-DI
- 69444138PSFX EUDAMED69444138S12SRA EUDAMED69444138Q12SQU EUDAMED69444138PRS5W EUDAMED69444138PAS4B 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 | 69444138PSFX | 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 (22)
- EUDAMED 646cf386-920b-466c-bba0-d1c3faa47527 61 fields · synced Sep 30, 2026
- EUDAMED 2c28f6ad-2db4-40e3-8a27-29f6790314cf 61 fields · synced May 17, 2026
- EUDAMED aa312ca9-b095-4ef7-931f-81eb3e6fabfb 61 fields · synced May 19, 2026
- EUDAMED b4f8a08b-0c13-435c-a0a3-5c95aa4a9ad1 61 fields · synced Jun 18, 2026
- EUDAMED ecb16df3-1d98-4b9b-9afa-4b022547f3c9 61 fields · synced Jun 18, 2026
- EUDAMED 2bf129e8-350e-437b-8348-6965fd71674b 61 fields · synced Jun 19, 2026
- EUDAMED dd64968d-bd82-4bef-aeb2-0f8a2c349b7c 61 fields · synced Jun 20, 2026
- EUDAMED 239cc8bd-e458-40cf-8a61-2db810f61606 61 fields · synced Jul 9, 2026
- EUDAMED 3702301b-7cf1-4110-a399-77ed95855a5b 61 fields · synced Jul 9, 2026
- EUDAMED 48f91439-a321-423e-b300-fc58da000d6a 61 fields · synced Jul 10, 2026
- EUDAMED 5a4dea6b-93c8-40c3-943a-a18e77c720f8 61 fields · synced Jul 11, 2026
- EUDAMED 1fd4d43f-5b01-4785-8985-3df3125d9956 61 fields · synced Jul 12, 2026
- EUDAMED f20e9482-e686-4cec-86d4-4b7a72bea7dc 61 fields · synced Jul 14, 2026
- EUDAMED f2a6b26a-64e3-45d0-aa55-9f13ebf3cc48 61 fields · synced Jul 14, 2026
- EUDAMED d50ae5bf-69e4-4848-9ead-e7c341786648 61 fields · synced Jul 14, 2026
- EUDAMED 41f1efad-9e18-4d32-b5d7-8e2f8dc294ee 61 fields · synced Jul 17, 2026
- EUDAMED bf113669-4ef2-4900-90d7-5dfce9098342 61 fields · synced Jul 22, 2026
- EUDAMED fd001369-9fb8-48cf-9b7e-d2cf1d49fb17 61 fields · synced Jul 22, 2026
- EUDAMED 928a0968-fa62-4e2c-b219-e9b536351d59 61 fields · synced Jul 25, 2026
- EUDAMED 2d712f7f-aa15-446a-9117-665e05b1c7aa 61 fields · synced Jul 29, 2026
- EUDAMED 381acfba-2adf-418b-8925-19537d4966d7 61 fields · synced Aug 2, 2026
- EUDAMED abc62f4d-9dc5-471f-bc6b-bacc75604390 61 fields · synced Aug 3, 2026