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2000 Series Revised ETDRS Chart 3 Sloan Letters for 2 meters testing
EUDAMEDClass I (EU MDR)
Ref 2137
Identity
- Trade Name
- 2000 Series Revised ETDRS Chart 3 Sloan Letters for 2 meters testing EUDAMED
- Device Name
- Vision Testing Chart EUDAMED
- Model / Reference
- 2137 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286032285 EUDAMED
- Basic UDI-DI
- 081128603PVChartsLF EUDAMED
- Direct Marketing DI
- 00811286032285 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
2000 Series Revised ETDRS Chart 3 Sloan Letters for 2 meters testing 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 ac0dc6d0-d85f-4c3c-9658-05e16c9f962a 61 fields · synced Jul 20, 2026