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Slit Lamp Microscope
EUDAMEDFDA UDIFDA 510(k)Class 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-5500 FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- Slit Lamp Microscope EUDAMED-. Magnfication : 5 position rotation drum -. Lamp : Halogen Bulb ( 12V 30W ) 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-5500(HLG) FDA UDI
- Description
- -. Magnfication : 5 position rotation drum -. Lamp : Halogen Bulb ( 12V 30W ) FDA UDI
Identifiers
- Catalog Number
- HS-5500(HLG) FDA UDI
- Primary DI / UDI-DI
- 08800019600015 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196HS001DT EUDAMED
- Direct Marketing DI
- 08800019600015 EUDAMED
- 510(k) Number
- K093639 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073190 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 88000196HS001DT | Class I | Active |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED e2694ca2-63c3-474b-9f58-d039d61134e0 61 fields · synced Jul 17, 2026
- FDA UDI bf0db7e3-dd79-42cb-8b73-ec325750e7a1 36 fields · synced May 30, 2026
- FDA 510(k) K073190 1 fields · synced May 18, 2026