Identity
- Trade Name
- Binoptometer 4P EUDAMEDBinoptometer® 4P incl. integrated electromotoric height adjustment FDA UDI
- Generic Name
- Binocular vision test unit FDA UDI
- Device Name
- Binoptometer EUDAMEDBinoptometer® 4P incl. integrated electromotoric height adjustment FDA UDI
- Model / Reference
- 59860 EUDAMEDFDA UDI
- Description
- Binoptometer® 4P incl. integrated electromotoric height adjustment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584010032 EUDAMEDFDA UDI
- Basic UDI-DI
- 404958410PL EUDAMED
- FDA Product Code
- HJQ FDA UDIHOX FDA UDI
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
- GMDN Term
- Binocular vision test unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1870 FDA UDI886.1150 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Binoptometer 4P 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 | 404958410PL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- EUDAMED SRN
- DE-MF-000012227
Sources (2)
- EUDAMED 2bad031b-567f-41c4-a56b-594a6ff6d432 61 fields · synced Aug 2, 2026
- FDA UDI e37f23ac-385a-4d43-87f2-a4e7171b706b 34 fields · synced May 30, 2026