Identity
- Trade Name
- Optex-GS EUDAMED
- Device Name
- Optex-GS Filter Unit EUDAMED
- Model / Reference
- SPGS0255W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053252464010 EUDAMED
- Basic UDI-DI
- B-04053252464010 EUDAMED
- EMDN Code
- A04010101 WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optex-GS by Merck Millipore Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04053252464010 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merck Millipore Ltd
- EUDAMED SRN
- IE-MF-000003997
Sources (1)
- EUDAMED fd992dd1-c293-49cd-985e-6f0ac6cc118d 61 fields · synced Jun 18, 2026