MiiS Horus Scope DPT 100
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- MiiS Horus Scope EUDAMED
- Device Name
- Digital Eye Anterior Camera (Lens) EUDAMEDDigital Dermatoscope EUDAMEDDigital Otoscope (Lens) EUDAMEDEndoscope Adapter EUDAMEDBronchoscope EUDAMEDDigital Eye Anterior Camera (Lens), Digital Eye Surface Camera (Lens) EUDAMEDDigital Dermatoscope (Lens) EUDAMEDControl unit EUDAMEDDigital Eye Fundus Camera (Lens) EUDAMED
- Model / Reference
- DEA series EUDAMEDMiiS Horus+ Scope DEA 200 EUDAMEDMPD series EUDAMEDMPD 100 EUDAMEDDOC series, EOC series EUDAMEDMiiS Horus Scope DOC 300S EUDAMEDMiiS Horus Scope DOC 100S EUDAMEDAdapter EUDAMEDMiiS Horus Scope Adapter 300 EUDAMEDECB series EUDAMEDECB 100S EUDAMEDDEA 100, DGC 200 EUDAMEDMiiS Horus Scope DEA 100 EUDAMEDDDC series EUDAMEDMiiS Horus Scope DDC 100 EUDAMEDMiiS Horus Scope DDC 200 EUDAMEDECB 100L EUDAMEDDSC series EUDAMEDMiiS Horus Scope DSC 100 EUDAMEDMiiS Horus Scope DSC 300 EUDAMEDMiiS Horus Scope DEA 200P EUDAMEDMiiS Horus Scope DSC 300P EUDAMEDDEC series, EEC series EUDAMEDMiiS Horus Scope EEC 100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872711063 EUDAMED04719872713036 EUDAMED04719872712053 EUDAMED04719872712046 EUDAMED04719872712060 EUDAMED04719872715108 EUDAMED04719872711025 EUDAMED04719872713012 EUDAMED04719872713029 EUDAMED14719872715129 EUDAMED04719872710011 EUDAMED04719872710066 EUDAMED04719872711100 EUDAMED04719872710073 EUDAMED04719872711032 EUDAMED
- Basic UDI-DI
- 47198727110017V EUDAMED47198727130078P EUDAMED471987271200082 EUDAMED471987271200184 EUDAMED47198727150028T EUDAMED47198727110027X EUDAMED471987271300089 EUDAMED47198727100007L EUDAMED47198727110007T EUDAMED
- Direct Marketing DI
- 04719872711063 EUDAMED04719872713036 EUDAMED04719872712053 EUDAMED04719872712046 EUDAMED04719872712060 EUDAMED04719872715108 EUDAMED04719872711025 EUDAMED04719872713012 EUDAMED04719872713029 EUDAMED14719872715129 EUDAMED04719872710011 EUDAMED04719872710066 EUDAMED04719872711100 EUDAMED04719872710073 EUDAMED04719872711032 EUDAMED
- 510(k) Number
- K181260 FDA 510(k)
- FDA Product Code
- HKX FDA 510(k)
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMEDZ12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMEDZ12021009 DIRECT OUTPATIENT VIDEO-OTOSCOPES EUDAMEDZ12029080 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES EUDAMEDZ12020802 VIDEO BRONCHOSCOPES EUDAMEDZ12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMEDZ12040108 DERMATOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1930 FDA 510(k)
- Regulation Number
- 886.1930 FDA 510(k)
- Market of Registration
- France EUDAMEDSpain EUDAMEDGermany EUDAMEDNetherlands EUDAMEDLithuania EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The MiiS Horus Scope DPT 100 is an ac-powered tonometer, a diagnostic device used to measure intraocular pressure (IOP) in the eye. Classified as a Class II medical device, it is designed for ophthalmic applications, specifically to assist in the assessment of glaucoma and other conditions requiring IOP monitoring. Its design integrates advanced technology to provide accurate readings for clinical decision-making.
This device is supplied as a reusable, non-sterile instrument intended for use in clinical settings such as ophthalmology offices, hospitals, or diagnostic centers. It operates using AC power and is regulated under FDA 510(k) clearance (K181260) and the EU Medical Device Regulation (MDR). The device is not MRI-safe, and its specifications include multiple FEI numbers (e.g., 1000391004) and registration numbers (e.g., 9611269) under regulatory oversight. Storage and maintenance follow manufacturer guidelines to ensure operational reliability.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181260 | Class II | Active |
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Manufacturer
- Manufacturer
- Medimaging Integrated Solution, Inc (Miis)
Sources (16)
- FDA 510(k) K181260 24 fields · synced Sep 18, 2026
- EUDAMED ff76f388-a051-44af-b781-10dbba6f63ce 61 fields · synced Jun 20, 2026
- EUDAMED 0466983f-ecd3-4de1-999d-f70b79cc6373 61 fields · synced Jul 9, 2026
- EUDAMED fcf4d33e-115d-4152-a176-d5dcee3cd212 61 fields · synced Jul 9, 2026
- EUDAMED cd24c646-a1d1-4388-a046-f24e000fa800 61 fields · synced Jul 10, 2026
- EUDAMED ae7324eb-bce4-4c3e-962d-d03c0c529e8b 61 fields · synced Jul 11, 2026
- EUDAMED ba29a485-46c1-45e0-8bed-9e58bf87106b 61 fields · synced Jul 12, 2026
- EUDAMED 270727c6-93a6-4469-a6f7-404940cdbc9d 61 fields · synced Jul 18, 2026
- EUDAMED cde82547-f71f-4ff1-820b-0941a0597df6 61 fields · synced Jul 19, 2026
- EUDAMED c1eda489-82fa-4f47-a98f-5ef799cd69b0 61 fields · synced Jul 20, 2026
- EUDAMED c6aef371-98b9-4386-83e4-82e121a1f325 61 fields · synced Jul 22, 2026
- EUDAMED 5caae8fc-56c4-41e1-ae35-5da8ca65787d 61 fields · synced Jul 27, 2026
- EUDAMED 071ea816-0602-4634-adaf-03e3dc3ede44 61 fields · synced Jul 28, 2026
- EUDAMED ffe38c4b-f635-4a97-b03f-64bff5ad2a23 61 fields · synced Jul 30, 2026
- EUDAMED bc86b7e6-c308-4a9e-a639-d1d02ad6c1de 61 fields · synced Aug 4, 2026
- EUDAMED d2fde4d0-09be-474f-9128-249006bafd66 61 fields · synced Sep 18, 2026