Bioness StimRouter Extended Hydrogel Electrode Set
FDA UDIEUDAMEDClass II (US FDA UDI)
by Bioness Inc.
Identity
- Trade Name
- Bioness StimRouter Extended Hydrogel Electrode Set FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- StimRouter Electrodes - L EUDAMEDExtended Hydrogel Electrode Set FDA UDI
- Model / Reference
- ST2-7001 EUDAMEDFDA UDI
- Description
- Extended Hydrogel Electrode Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815962020313 EUDAMEDFDA UDI
- Basic UDI-DI
- 081596202STRE002LB EUDAMED
- FDA Product Code
- GZF FDA UDI
- EMDN Code
- Z12101180 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5870 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Transcutaneous electrical stimulation electrode, reusable
Bioness StimRouter Extended Hydrogel Electrode Set by Bioness Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bioness Inc.
Sources (2)
- FDA UDI 4d4a1c1a-2689-491a-8361-2f898cd7cb70 35 fields · synced Jun 19, 2026
- EUDAMED 90c77b57-e127-4fce-a8f4-529f2ec11dd8 61 fields · synced Jun 19, 2026