Identity
- Trade Name
- MicroStacker™ Flex Polymer Detection Kit EUDAMED
- Device Name
- MicroStacker™ Flex Polymer Detection Kit EUDAMED
- Model / Reference
- SD5300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971804560004 EUDAMED
- Basic UDI-DI
- 697180456SD5300DK EUDAMED
- Direct Marketing DI
- 06971804560004 EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
MicroStacker™ Flex Polymer Detection Kit by Henan Celnovte Biotechnology 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 | 697180456SD5300DK | Class A | Active |
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Manufacturer
- Manufacturer
- Henan Celnovte Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022882
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 5f69bd48-830d-4bf4-9bf9-2b3889e4ebae 61 fields · synced Jul 10, 2026