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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-7500 FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- Slit Lamp Microscope EUDAMED" -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)" -. The SLIT LAMP is intended for use in eye examination of the anterior eye segments, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. 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-7500(LED) FDA UDI
- Description
- " -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)" -. The SLIT LAMP is intended for use in eye examination of the anterior eye segments, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. FDA UDI
Identifiers
- Catalog Number
- HS-7500(LED) FDA UDI
- Primary DI / UDI-DI
- 08800019600077 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196HS001DT EUDAMED
- Direct Marketing DI
- 08800019600077 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 — 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 6f5ff513-fa15-44b7-be89-bc4a868283bb 61 fields · synced Jul 25, 2026
- FDA UDI ac5f76a2-d059-416a-a774-8426c8f29be7 36 fields · synced May 30, 2026