Identity
- Trade Name
- HUVITZ EUDAMEDCorneal Topographer HTG-1 FDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Device Name
- Corneal Topographer;HTG-1, Auto Ref-Topographer;HRKT-1 EUDAMEDCorneal Topographer HTG-1 FDA UDI
- Model / Reference
- HTG-1, HRKT-1 EUDAMEDV2XXCL-21-00001 EUDAMEDHTG-1 FDA UDI
- Description
- Corneal Topographer HTG-1 FDA UDI
Identifiers
- Catalog Number
- HTG-1 FDA UDI
- Primary DI / UDI-DI
- 08800019600770 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196TG001FB EUDAMED
- Direct Marketing DI
- 08800019600770 EUDAMED
- FDA Product Code
- MMQ FDA UDI
- EMDN Code
- Z12120123 COMPUTERISED CORNEAL TOPOGRAPHS EUDAMED
- GMDN Term
- Corneal topography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1350 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
Huvitz 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 | 88000196TG001FB | 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 0a9db723-ee5e-4d2d-ac48-ccf78ac364b6 61 fields · synced Jul 9, 2026
- FDA UDI fbb49e6f-af8e-4149-971c-23467b1fa821 35 fields · synced May 30, 2026