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Cleating Solution (System maintenance type)
EUDAMEDClass A (EU MDR)
Ref CK-WH-001Model System maintenance type.
Identity
- Device Name
- Cleating Solution (System maintenance type) EUDAMED
- Model / Reference
- System maintenance type. EUDAMEDCK-WH-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926980318628 EUDAMED
- Basic UDI-DI
- 697314772CSSMT001EA 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
Cleating Solution (System maintenance type) 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 | 697314772CSSMT001EA | 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 (1)
- EUDAMED 53e49d5d-e8c1-4bf4-b071-10e8612d4ed1 61 fields · synced Jul 17, 2026