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Konan Specular Microscope XX CellChek 20-1 PLUS
EUDAMEDFDA UDIClass I (EU MDR)
Ref N/A
Identity
- Trade Name
- Konan Specular Microscope XX CellChek 20-1 PLUS EUDAMEDNA FDA UDI
- Generic Name
- Eye anterior segment analyser FDA UDI
- Device Name
- N/A EUDAMED
- Model / Reference
- N/A EUDAMEDCellChek 20-1 PLUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582275250671 EUDAMEDFDA UDI
- Basic UDI-DI
- 458227526KONAN-CSPKZ EUDAMED
- Direct Marketing DI
- 04582275250671 EUDAMED
- 510(k) Number
- K191558 FDA UDI
- FDA Product Code
- NQE FDA UDI
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Eye anterior segment analyser 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Konan Specular Microscope XX CellChek 20-1 PLUS by Konan Medical, Inc. — 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 | 458227526KONAN-CSPKZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Konan Medical, Inc.
- EUDAMED SRN
- JP-MF-000005193
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED a90c4bf2-0b59-4ca5-b08d-5c09dc65abc9 61 fields · synced Jun 20, 2026
- FDA UDI 9795f528-c6f8-4c62-859a-f2fb3cf980d0 33 fields · synced May 30, 2026