Hpmc Sida-Pack
Ref 10011-10
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number521301331HPMCYS 05213013314896 | Date19 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Set of Hypromellose Ophthalmic Solutions 2% & PVA Eye Spears
- Model / Reference
- 10011-10
- Primary DI / UDI-DI
- 05213013314896
- Basic UDI-DI
- 521301331HPMCYS
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class IIb
- Medical Purpose
- SIDA-HPMC 2% is intended to be used as an ophthalmic surgical aid in anterior segment surgical procedures. It maintains a deep chamber during anterior segment surgery and thereby allows for more efficient manipulation with significantly less trauma to the corneal endothelium and other ocular tissues. Its clinical benefit is that it can be used as an OVD (ophthalmic viscoelastic device) during cataract surgery. The PVA Eye Spear is intended to be used for absorbing or mopping fluids from the operative field.
Manufacturer details
- EUDAMED SRN
- EL-PR-000050928