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Fluorescence & Bright-Field Multifunctional Digital Pathology Scanner
EUDAMEDClass A (EU MDR)
Ref 06976873690126Model KR-MD9-PLUS
Identity
- Trade Name
- Fluorescence & Bright-Field Multifunctional Digital Pathology Scanner EUDAMED
- Device Name
- Fluorescence & Bright-Field Multifunctional Digital Pathology Scanner EUDAMED
- Model / Reference
- KR-MD9-PLUS EUDAMED06976873690126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976873690126 EUDAMED
- Basic UDI-DI
- 697687369MD9Z4 EUDAMED
- Direct Marketing DI
- 06976873690126 EUDAMED
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Fluorescence & Bright-Field Multifunctional Digital Pathology Scanner by Jiangsu KR Pharmetech Co., Ltd. — Class A — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697687369MD9Z4 | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu KR Pharmetech Co., Ltd.
- EUDAMED SRN
- CN-MF-000051331
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 96dc0e3a-b2e7-4286-8010-69174921ff88 61 fields · synced Jun 19, 2026