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SCRAMBLED - Pocket Size Near Vision Card with Continuous Text for 40 cm (16 in)…
EUDAMEDClass I (EU MDR)
Ref 2113C
Identity
- Trade Name
- SCRAMBLED - Pocket Size Near Vision Card with Continuous Text for 40 cm (16 in) Testing. EUDAMED
- Device Name
- Vision Testing Chart EUDAMED
- Model / Reference
- 2113C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286037235 EUDAMED
- Basic UDI-DI
- 081128603PVChartsLF EUDAMED
- Direct Marketing DI
- 00811286037235 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
SCRAMBLED - Pocket Size Near Vision Card with Continuous Text for 40 cm (16 in)… 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 def38289-05f3-4f1f-93ae-90b6b1683d8f 61 fields · synced Jun 20, 2026