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OPTISHIELD Silicone Optical Occluder (Black)
EUDAMEDClass I (EU MDR)
Ref 10318BK
Identity
- Trade Name
- OPTISHIELD Silicone Optical Occluder (Black) EUDAMED
- Device Name
- Ocular Occluders EUDAMED
- Model / Reference
- 10318BK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286036597 EUDAMED
- Basic UDI-DI
- 081128603Occluder59 EUDAMED
- Direct Marketing DI
- 00811286036597 EUDAMED
- EMDN Code
- Z1212012099 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
OPTISHIELD Silicone Optical Occluder (Black) by Precision Vision, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 081128603Occluder59 | Class I | Active |
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Manufacturer
- Manufacturer
- Precision Vision, Inc.
- EUDAMED SRN
- US-MF-000008456
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (1)
- EUDAMED e80c6fe6-13e0-41f2-b462-de23d10bb437 61 fields · synced Jul 12, 2026