Identity
- Trade Name
- Konan CellChek D CD-15 EUDAMEDNA FDA UDI
- Generic Name
- Cell morphology analyser IVD, manual FDA UDI
- Device Name
- N/A EUDAMED
- Model / Reference
- N/A EUDAMEDCD-15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582275250404 EUDAMEDFDA UDI
- Basic UDI-DI
- 458227526KONAN-ESPLB EUDAMED
- Direct Marketing DI
- 04582275250404 EUDAMED
- 510(k) Number
- K040373 FDA UDI
- FDA Product Code
- NQE FDA UDI
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES EUDAMED
- GMDN Term
- Cell morphology analyser IVD, manual FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
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 CellChek D CD-15 by Konan Medical, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 458227526KONAN-ESPLB | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 ab455b53-5969-4204-bb33-c2b27d1851ec 61 fields · synced Jun 18, 2026
- FDA UDI d9c54fdb-edac-4cae-8adc-8383b6ed1376 33 fields · synced May 30, 2026