Osseous
by Eon Meditech Pvt. Ltd 39 variants
Ref E7167Model PVA Dressing
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-08906039310672 08906039310672 | Date4 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number08906039310672 | Date11 Jun 2024 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Ear wick, non-biodegradable
- Device Name
- Ear Pack with String (12.0Dia.x15.0)mm
- Model / Reference
- PVA Dressing, E7167
- Primary DI / UDI-DI
- 08906039310672
- Basic UDI-DI
- B-08906039310672
- FDA Product Code
- KCN
- EMDN Code
- Q030499 Otology devices - other
- GMDN Term
- Ear wick, non-biodegradable
- Device Class
- Class I
- Regulation Number
- 874.5220
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 12 MillimeterLength — 15 Millimeter
Manufacturer details
- EUDAMED SRN
- IN-MF-000014457
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Eon Meditech Pvt. Ltd
Properties
Other properties (14)
- 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
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No