N/A 520856
by inomed Medizintechnik GmbH EUDAMEDGUDID
Active
Ref 520856
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-04250307612079 | Date1 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04250307612079 | Date2 May 2025 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- Tubus-Klebeelektrode Select für Tuben 7-9 mm ID EUDAMEDN/A GUDID
- Generic Name
- Electromyographic endotracheal tube electrode
- Model / Reference
- 520856
- Primary DI / UDI-DI
- 04250307612079
- Basic UDI-DI
- B-04250307612079
- FDA Product Code
- ETN
- EMDN Code
- Z12100480 Electromyography instruments - hardware accessories
- GMDN Term
- Electromyographic endotracheal tube electrode
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 874.1820
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from inomed Medizintechnik GmbH
Properties
Other properties (16)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No