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Slit Lamp Microscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref JOARAA-17-00001Model HS-5000, HS-5000(X2), HS-5000(X3), HS-5500, HS-7000, HS-7500 and HIS-5000U
Identity
- Trade Name
- maging System HIS-5000U FDA UDI
- Generic Name
- Multidisciplinary medical image management software FDA UDI
- Device Name
- Slit Lamp Microscope EUDAMEDimaging system is intended for help observation and recording of eye using a slit lamp FDA UDI
- Model / Reference
- HS-5000, HS-5000(X2), HS-5000(X3), HS-5500, HS-7000, HS-7500 and HIS-5000U EUDAMEDJOARAA-17-00001 EUDAMEDHIS-5000U FDA UDI
- Description
- imaging system is intended for help observation and recording of eye using a slit lamp FDA UDI
Identifiers
- Catalog Number
- HIS-5000U FDA UDI
- Primary DI / UDI-DI
- 08800019600121 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196HS001DT EUDAMED
- Direct Marketing DI
- 08800019600121 EUDAMED
- FDA Product Code
- NVV FDA UDI
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
- GMDN Term
- Multidisciplinary medical image management software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2100 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Slit Lamp Microscope 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 | 88000196HS001DT | 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 acb00120-0428-4b52-a61c-3d13c09754ea 61 fields · synced Jun 19, 2026
- FDA UDI 511e2c1a-a19e-4d3a-9ec7-f6831aa49bfd 35 fields · synced May 30, 2026