← Back to catalogue
Slit Lamp Microscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref J0ARAA-16-00001Model HS-5000, HS-5000(X2), HS-5000(X3), HS-5500, HS-7000, HS-7500 and HIS-5000U
Identity
- Trade Name
- Slit Lamp HS-5000 FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- Slit Lamp Microscope EUDAMED-. Magnfication : 3 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W) FDA UDI
- Model / Reference
- HS-5000, HS-5000(X2), HS-5000(X3), HS-5500, HS-7000, HS-7500 and HIS-5000U EUDAMEDJ0ARAA-16-00001 EUDAMEDHS-5000 FDA UDI
- Description
- -. Magnfication : 3 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W) FDA UDI
Identifiers
- Catalog Number
- HS-5000 FDA UDI
- Primary DI / UDI-DI
- 08800019600114 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196HS001DT EUDAMED
- Direct Marketing DI
- 08800019600114 EUDAMED
- 510(k) Number
- K073190 FDA UDI
- FDA Product Code
- HJO FDA UDI
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 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 |
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 0b87cc49-3618-4daa-b0a1-46d2314fe4cd 61 fields · synced Jul 12, 2026
- FDA UDI b0293404-63ef-4be6-8062-41d382b787ac 37 fields · synced May 30, 2026