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High Contrast ETDRS Sloan Letters for testing at 3 meters (2425) (HC-1)
EUDAMEDClass I (EU MDR)
Ref 2134
Identity
- Trade Name
- High Contrast ETDRS Sloan Letters for testing at 3 meters (2425) (HC-1) EUDAMED
- Device Name
- Vision Testing Chart EUDAMED
- Model / Reference
- 2134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286032254 EUDAMED
- Basic UDI-DI
- 081128603PVChartsLF EUDAMED
- Direct Marketing DI
- 00811286032254 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
High Contrast ETDRS Sloan Letters for testing at 3 meters (2425) (HC-1) by Precision Vision, Inc. — Class I — MDR — listed in EUDAMED
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 | 081128603PVChartsLF | 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 5bcd040f-2327-4d28-9485-9e1377b023fe 61 fields · synced Sep 18, 2026