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Sloan Letters ETDRS 2000 Series, Charts 1 and 2 printed on white styrene plastic
EUDAMEDClass I (EU MDR)
Ref 2106-80
Identity
- Trade Name
- Sloan Letters ETDRS 2000 Series, Charts 1 and 2 printed on white styrene plastic EUDAMED
- Device Name
- Vision Testing Chart EUDAMED
- Model / Reference
- 2106-80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286030625 EUDAMED
- Basic UDI-DI
- 081128603PVChartsLF EUDAMED
- Direct Marketing DI
- 00811286030625 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
Sloan Letters ETDRS 2000 Series, Charts 1 and 2 printed on white styrene plastic 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 baf9fe9d-5815-4d48-aa9f-1beab03e8e0e 61 fields · synced Jun 19, 2026