← Back to catalogue
OCTavius
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref W2XXCL-21-00008Model HOCT-1F, HOCT-1
Identity
- Trade Name
- OCTavius EUDAMEDOptical Coherence Tomography HOCT-1F FDA UDI
- Generic Name
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
- Device Name
- Optical Coherence Tomography EUDAMEDIt is intended for use as a diagnostic device to aid in the check and management of ocular diseases such as macular holes, cystoid macular edema, diabetic retinopathy, aged related macular degeneration, and so on FDA UDI
- Model / Reference
- HOCT-1F, HOCT-1 EUDAMEDW2XXCL-21-00008 EUDAMEDHOCT-1F FDA UDI
- Description
- It is intended for use as a diagnostic device to aid in the check and management of ocular diseases such as macular holes, cystoid macular edema, diabetic retinopathy, aged related macular degeneration, and so on FDA UDI
Identifiers
- Catalog Number
- HOCT-1F FDA UDI
- Primary DI / UDI-DI
- 08800019600497 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196CT001CB EUDAMED
- Direct Marketing DI
- 08800019600497 EUDAMED
- FDA Product Code
- OBO FDA UDI
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
- GMDN Term
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 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
Yes
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
OCTavius by Huvitz Co., Ltd. — Class IIa — 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 | 88000196CT001CB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 6295ab1f-2dc8-4782-9fa5-432c1bb9646a 61 fields · synced Jul 20, 2026
- FDA UDI ccdd00c6-b401-4461-939a-e41c27ea8697 35 fields · synced May 30, 2026