Identity
- Device Name
- Substrate Solution EUDAMED
- Model / Reference
- CK-DW-007 EUDAMEDCK-DW-008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926980318598 EUDAMED06926980318604 EUDAMED
- Basic UDI-DI
- 697314772SSFAITS001UU EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Substrate Solution by Guangzhou Kangrun Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697314772SSFAITS001UU | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Kangrun Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000032267
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED b61367a6-8e96-4e87-a677-8ac403efdd44 61 fields · synced Jul 22, 2026
- EUDAMED 7ba00fae-0fc9-486e-8db7-2cdf8cec7dca 61 fields · synced May 18, 2026