Identity
- Device Name
- HEMATOLOGY ANALYSIS LYTIC AGENT EUDAMED
- Model / Reference
- 06970293022581 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970293022581 EUDAMED
- Basic UDI-DI
- 697029302lytic0013N EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
No
EUDAMED
New Device
No
EUDAMED
Hematology Analysis Lytic Agent by Zhejiang xinke Medical Technology 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 | 697029302lytic0013N | Class A | Active |
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Manufacturer
- Manufacturer
- Zhejiang xinke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032274
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED b96c8c38-26c0-4360-8c9f-e0f85f9411ff 61 fields · synced Jun 18, 2026