Identity
- Trade Name
- Optotypentafel für H-Test EUDAMEDVisual acuity chart for H-Test FDA UDI
- Generic Name
- Vision testing/training chart FDA UDI
- Device Name
- Visual acuity charts EUDAMEDVisual acuity chart for H-Test FDA UDI
- Model / Reference
- 47304 EUDAMEDFDA UDI
- Description
- Visual acuity chart for H-Test FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584006783 EUDAMEDFDA UDI
- Basic UDI-DI
- 404958418Q4 EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Z1212012099 INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER EUDAMED
- GMDN Term
- Vision testing/training chart FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Optotypentafel für H-Test by OCULUS Optikgeräte GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 404958418Q4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- EUDAMED SRN
- DE-MF-000012227
Sources (2)
- EUDAMED 5839b688-81ea-4cb0-907b-c9b167ab7f66 61 fields · synced Jul 17, 2026
- FDA UDI 5d8e6c89-e59c-4efd-b896-d0d4f43a6431 34 fields · synced May 30, 2026