Identity
- Trade Name
- Subdermal Needles EUDAMEDRhythmlink® FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Subdermal Needle Electrodes EUDAMED4 electrodes, 13mm long, 0.4mm diameter disposable 5 twist subdermal needle with touch proof connector FDA UDI
- Model / Reference
- RLSP484 EUDAMEDFDA UDI
- Description
- 4 electrodes, 13mm long, 0.4mm diameter disposable 5 twist subdermal needle with touch proof connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816312022407 EUDAMEDFDA UDI
- Basic UDI-DI
- 081631202TF001TW EUDAMED
- FDA Product Code
- GXZ FDA UDI
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 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
Dimensions & Sizes
- Size
- Length — 13 Millimeter FDA UDI
Subdermal Needles by Rhythmlink International, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 081631202TF001TW | 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 8cd07256-b4a1-4e55-998b-e5c8a80c6671 61 fields · synced Aug 3, 2026
- FDA UDI bf8ec97a-4965-4a95-bb58-96a3e1e91c8e 35 fields · synced May 29, 2026