Identity
- Trade Name
- Optigard Double Foam EUDAMED
- Device Name
- Optigard EUDAMED
- Model / Reference
- 91002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033976721640 EUDAMED
- Basic UDI-DI
- 803397672OPT91000ZR EUDAMED
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Radiation/mechanical corneal shield, reusable
Optigard Double Foam by WELCARE INDUSTRIES S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803397672OPT91000ZR | Class I | Active |
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Manufacturer
- Manufacturer
- WELCARE INDUSTRIES S.p.A.
- EUDAMED SRN
- IT-MF-000020870
Sources (1)
- EUDAMED 4272aded-869a-4a43-8afa-423588a8a737 61 fields · synced Jul 9, 2026