Identity
- Trade Name
- Hubtisch EUDAMEDOphthalmic table Twinfield and laptop, 230 V FDA UDI
- Generic Name
- Ophthalmic instrument table, line-powered FDA UDI
- Device Name
- Hubtisch EUDAMEDOphthalmic table Twinfield and laptop, 230 V FDA UDI
- Model / Reference
- 37660 EUDAMEDFDA UDI
- Description
- Ophthalmic table Twinfield and laptop, 230 V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584027535 EUDAMEDFDA UDI
- Basic UDI-DI
- 404958422PT EUDAMED
- FDA Product Code
- HRJ FDA UDI
- EMDN Code
- Z12129001 OPHTHALMOLOGICAL INSTRUMENT STANDS EUDAMED
- GMDN Term
- Ophthalmic instrument table, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4855 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
Hubtisch 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 | 404958422PT | 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 35082e85-800a-4a3d-acb6-1434d232c7d0 61 fields · synced Jun 18, 2026
- FDA UDI dbcf98d0-4f0c-4944-8d6b-fc7433d49146 34 fields · synced May 30, 2026