Identity
- Trade Name
- Precision Vision ETDRS Illuminator Cabinet EUDAMED
- Device Name
- Precision Vision ETDRS Illuminator Cabinet EUDAMED
- Model / Reference
- 2425Ev4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286033244 EUDAMED
- Basic UDI-DI
- 081128603PVCabinet9N EUDAMED
- Direct Marketing DI
- 00811286033244 EUDAMED
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT 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
Precision Vision ETDRS Illuminator Cabinet 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 | 081128603PVCabinet9N | 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 ebc1373c-1061-44bf-9c0e-ca271ecc1832 61 fields · synced Jul 11, 2026