Basic Information
- Primary DI
- D-4897082940180CA
- Basic UDI-DI Code
- B-4897082940180CA
- Reference
- ENT05
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Gofarm Sp. z o.o. Sp. k.
Additional Description
VIVO Ear Drops is a preparation intended for removing residual wax from the ear and to prevent its recurrence. The preparation is used as an adjunct to clear the ear from secretions resulting from the otitis externa, in particular the auricle of fungal and bacterial etiology, manifested by itching of the ear and redness of the skin of the ear canal with or without slight edema. The product contains no preservatives, parabens, or propellants. Indications: • Unblocks the ear canal and removes residual secretion in the ear. • Prevents reaccumulation of earwax. • Cleaning the ear from secretions resulting from the otitis externa,
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q03040201 | EAR DROPPERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 1434-MDD-184/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).