Identity
- Trade Name
- Black Occluder/Maddox Rod Occluder EUDAMED
- Device Name
- Ocular Occluders EUDAMED
- Model / Reference
- 10312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286030236 EUDAMED
- Basic UDI-DI
- 081128603Occluder59 EUDAMED
- Direct Marketing DI
- 00811286030236 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
Black Occluder/Maddox Rod Occluder 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 f4a22e81-9a0b-4611-8d21-a1670bf344c5 61 fields · synced Jul 11, 2026