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Refraction Table
EUDAMEDFDA UDIClass I (EU MDR)
Ref F2VSSM-20-00001Model HRT-7000, CIT-4000
Identity
- Trade Name
- Opthalmic Table HRT-7000 FDA UDI
- Generic Name
- Ophthalmic instrument table, line-powered FDA UDI
- Device Name
- Refraction Table EUDAMEDOpthalmic Table is produced for being used by loading the necessary equipment for the medical care act. FDA UDI
- Model / Reference
- HRT-7000, CIT-4000 EUDAMEDF2VSSM-20-00001 EUDAMEDHRT-7000 FDA UDI
- Description
- Opthalmic Table is produced for being used by loading the necessary equipment for the medical care act. FDA UDI
Identifiers
- Catalog Number
- HRT-7000 FDA UDI
- Primary DI / UDI-DI
- 08800019600244 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196RT001HG EUDAMED
- Direct Marketing DI
- 08800019600244 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
Refraction Table by Huvitz Co., Ltd. — 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 | 88000196RT001HG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 6cde43bf-353a-43d9-93ff-83436325e632 61 fields · synced Jun 19, 2026
- FDA UDI 3bc12553-aa87-4254-ae5e-e4b850cf33db 35 fields · synced May 29, 2026