Identity
- Trade Name
- Monopolar Stimulating Probe EUDAMEDRhythmlink® FDA UDI
- Generic Name
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
- Device Name
- Electrical Neuromuscular Stimulating Probes EUDAMEDOracle Monopolar Stimulating Probe FDA UDI
- Model / Reference
- RLSP210-03 EUDAMEDFDA UDI
- Description
- Oracle Monopolar Stimulating Probe FDA UDI
Identifiers
- Catalog Number
- 03.809.692S FDA UDI
- Primary DI / UDI-DI
- 00816312022216 EUDAMEDFDA UDI
- Basic UDI-DI
- 081631202TF002TY EUDAMED
- FDA Product Code
- ETN FDA UDI
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
- GMDN Term
- Diagnostic peripheral nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Point aesthesiometer
Monopolar Stimulating Probe by Rhythmlink International, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081631202TF002TY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Rhythmlink International, LLC
- EUDAMED SRN
- US-MF-000012131
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 5338bc55-fc46-4f07-b6af-aa0c19c134ea 61 fields · synced Jul 20, 2026
- FDA UDI cb296964-0605-4870-828e-672361d75886 35 fields · synced May 30, 2026