Identity
- Trade Name
- ENLIGHT PATIENT REFERENCE CABLE FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- The reference cable is connected to a common ECG-like electrode applied to the patient to acquire reference signal of electric impedance data. The accessory has been developed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. FDA UDI
- Model / Reference
- ACE-00034 FDA UDI
- Description
- The reference cable is connected to a common ECG-like electrode applied to the patient to acquire reference signal of electric impedance data. The accessory has been developed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898966433290 FDA UDI
- 510(k) Number
- DEN170072 FDA UDI
- FDA Product Code
- QEB FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1505 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analytical non-scalp cutaneous lead
Enlight Patient Reference Cable by Timpel S/A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Analytical non-scalp cutaneous lead.
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Cleared under the same submission
DEN170072 also covers:
- ENLIGHT 1810 — Timpel S/A
- ENLIGHT 2100 — Timpel S/A
- ENLIGHT BELT - L – LEFT — Timpel S/A
- ENLIGHT BELT - L – LEFT — Timpel S/A
- ENLIGHT BELT - L – RIGHT — Timpel S/A
- ENLIGHT BELT - L – RIGHT — Timpel S/A
- ENLIGHT BELT - M – LEFT — Timpel S/A
- ENLIGHT BELT - M – LEFT — Timpel S/A
- ENLIGHT BELT - M – RIGHT — Timpel S/A
- ENLIGHT BELT - M – RIGHT — Timpel S/A
- ENLIGHT BELT - S - LEFT — Timpel S/A
- ENLIGHT BELT - S - RIGHT — Timpel S/A
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Timpel S/A
Sources (1)
- FDA UDI 631bec36-9096-4b05-aca0-94cc67d624c2 34 fields · synced Jun 6, 2026