Nox Snap-on Lead, 100 cm
by Nox Medical EUDAMEDGUDID
Active
Ref 554022, 554025, 554027, 554028
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number1569431111NOX_EXGCABLES9M | Date28 Nov 2021 | StatusActive |
| United States | GUDID listing GUDID | Number15694311110293 | Date16 Sep 2016 | StatusIn distribution |
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- Withdrawn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 22 Oct 2026.
Specification
- Generic Name
- Electrocardiographic lead set, reusableAnalytical non-scalp cutaneous lead
- Device Name
- Snap-on Electrode Cables
- Model / Ref / Catalog
- 554022, 554025, 554027, 554028, NOX-ESNAP11PAC2, NOX-ESNAP8PAC1, NOX-PESNAP9PAC2, NOX-PESNAP10PAC2
- Primary DI / UDI-DI
- 15694311110293, 15694311110750, 15694311110774, 15694311110781, 15694311110354, 15694311110323, 15694311110347
- Basic UDI-DI
- 1569431111NOX_EXGCABLES9M
- Direct Marketing DI
- 15694311110293156943111103231569431111034715694311110354
- FDA Product Code
- IKD
- EMDN Code
- Z12100580 Polysomnography instruments - hardware accessories
- GMDN Term
- Electrocardiographic lead set, reusableAnalytical non-scalp cutaneous lead
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 890.1175
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 554022 554025 554027 554028 | NOX-ESNAP11PAC2 NOX-ESNAP8PAC1 NOX-PESNAP9PAC2 NOX-PESNAP10PAC2 |
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- IS-MF-000000950
Other devices from Nox Medical
Properties
Other properties (20)
- 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
- Expiration Date: No