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Subdermal Needles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RLSND829-2.5Ref RLSND506-2.5Ref RLSND826-2.5Ref RLSND511-1.5Ref RLSND111-1.5Ref RLSND503-2.5Ref RLSND132-2.5Ref RLSND831-2.5Ref RLSP450Ref RLSND814-1.5Ref RLSND825-2.5
Identity
- Trade Name
- Subdermal Needles EUDAMEDRhythmlink® FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Subdermal Needle Electrodes EUDAMED10 electrodes, 13mm long, 0.4mm diameter disposable paired subdermal needle with touch proof connector FDA UDI24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector FDA UDI10 electrodes, 13mm long, 0.4mm diameter disposable twisted subdermal needle with touch proof connector FDA UDI20 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector FDA UDI
- Model / Reference
- RLSND829-2.5 EUDAMEDFDA UDIRLSND826-2.5 EUDAMEDFDA UDIRLSND506-2.5 EUDAMEDFDA UDIRLSND503-2.5 EUDAMEDFDA UDIRLSND132-2.5 EUDAMEDFDA UDIRLSND825-2.5 EUDAMEDFDA UDIRLSND511-1.5 EUDAMEDFDA UDIRLSND831-2.5 EUDAMEDFDA UDIRLSND111-1.5 EUDAMEDFDA UDIRLSND814-1.5 EUDAMEDFDA UDIRLSP450 EUDAMEDFDA UDI
- Description
- 10 electrodes, 13mm long, 0.4mm diameter disposable paired subdermal needle with touch proof connector FDA UDI24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector FDA UDI10 electrodes, 13mm long, 0.4mm diameter disposable twisted subdermal needle with touch proof connector FDA UDI20 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816312020663 EUDAMEDFDA UDI00816312020601 EUDAMEDFDA UDI00816312021165 EUDAMEDFDA UDI00816312021127 EUDAMEDFDA UDI00816312020212 EUDAMEDFDA UDI00816312020588 EUDAMEDFDA UDI00816312021240 EUDAMEDFDA UDI00816312020700 EUDAMEDFDA UDI00816312020069 EUDAMEDFDA UDI00816312020366 EUDAMEDFDA UDI00816312022322 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 (22)
- EUDAMED 78722f7d-c804-4cf2-882a-a75e7cc935fe 61 fields · synced Aug 4, 2026
- FDA UDI 741e2b21-79cd-429f-b66f-f15db25f457b 35 fields · synced May 26, 2026
- FDA UDI b489a867-b109-4c30-8b07-6570d78c4869 35 fields · synced May 29, 2026
- FDA UDI 9865da41-ebe1-4004-b9e8-99b1c580b3c7 35 fields · synced May 30, 2026
- FDA UDI 2abae76f-bd15-42a3-8531-e5e544705839 35 fields · synced May 30, 2026
- FDA UDI 6f50e7b2-995d-406b-bcc2-2146ff2715a4 35 fields · synced May 30, 2026
- FDA UDI 196c43b1-43a2-45d5-9fca-875c79e28a39 35 fields · synced May 30, 2026
- FDA UDI 5312dc6b-51bc-418e-961c-a94e8deb1aa9 35 fields · synced May 30, 2026
- FDA UDI f8934a49-505c-4b9a-a291-4015cebe80f1 35 fields · synced May 30, 2026
- FDA UDI 2a9541e1-15d3-4b87-8e6a-5f4823a9b755 35 fields · synced May 30, 2026
- FDA UDI e853adc1-d16a-4de7-85d6-e1a482508ae3 35 fields · synced May 30, 2026
- FDA UDI 200af6ca-718a-4c59-b263-c2f96c8c6239 35 fields · synced May 30, 2026
- EUDAMED 52709683-9625-4e57-ab33-5ca3c3f417fe 61 fields · synced Jun 20, 2026
- EUDAMED 75878ef7-f0ef-4c03-8a7d-a9eb4ad92b2e 61 fields · synced Jul 9, 2026
- EUDAMED 60fcd573-3e6a-4200-8467-f504eb3c7b66 61 fields · synced Jul 17, 2026
- EUDAMED 9a01bcf0-d7c0-40a2-ac9a-3ba68c7c20e0 61 fields · synced Jul 26, 2026
- EUDAMED 3b87cfb3-b992-4c86-8b6b-aacedf991fc6 61 fields · synced Jul 29, 2026
- EUDAMED f452ed53-21ff-47de-bc32-4b9bd7485ea9 61 fields · synced Jul 29, 2026
- EUDAMED 456b69d4-49d1-4f3c-9e68-3d2669dcbdce 61 fields · synced Jul 31, 2026
- EUDAMED 31a7f2e9-501f-4d79-bb37-685a1ea3a9ad 61 fields · synced Jul 31, 2026
- EUDAMED 6e69985a-78c0-4df4-9d28-930bb5a25784 61 fields · synced Aug 1, 2026
- EUDAMED 58f9b07c-cfa2-462e-a4e6-9b08e39d4b82 61 fields · synced Aug 4, 2026