Identity
- Trade Name
- Lilly TM-Wick Electrode EUDAMEDFDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Lilly TM-Wick Electrode EUDAMED
- Model / Reference
- M013910 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817020020037 EUDAMEDFDA UDI
- Basic UDI-DI
- 08172002M013910GD EUDAMED
- 510(k) Number
- K063402 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Lilly TM-Wick Electrode by Intelligent Hearing Systems Corp. — Class I — 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 | 08172002M013910GD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Intelligent Hearing Systems Corp.
- EUDAMED SRN
- US-MF-000011473
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 06c8c745-edfd-45ae-8e06-ff69ee3eaa95 61 fields · synced Jul 21, 2026
- FDA UDI d7346096-0de5-4f33-8a77-50b6938f8167 33 fields · synced May 30, 2026