SIGNUM Connection System Cable
by Ad-Tech Medical Instrument Corp. EUDAMEDGUDID
Active
Ref L-JBL-48BDIN-11
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00841823110589 | Date9 Dec 2025 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number08418231RA6aJS | Date27 Jun 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Generic Name
- Analytical scalp lead
- Device Name
- Connection Systems
- Model / Ref / Catalog
- L-JBL-48BDIN-11
- Primary DI / UDI-DI
- 00841823110589
- Basic UDI-DI
- 08418231RA6aJS
- FDA Product Code
- IKD
- EMDN Code
- N010180 Neurophysiology devices - accessories
- GMDN Term
- Analytical scalp lead
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 890.1175
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Hydrogen Peroxide
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000004795
- Authorised representative
- E C REP LIMITED IE-AR-000003995
Other devices from Ad-Tech Medical Instrument Corp.
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No