Identity
- Device Name
- MCKD-05 EUDAMED
- Model / Reference
- MCKD-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976374330620 EUDAMED
- Basic UDI-DI
- 697637433MCKD-05SN EUDAMED
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Mckd-05 by Zenith Lab (Jiangsu) 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 | 697637433MCKD-05SN | Class A | Active |
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Manufacturer
- Manufacturer
- Zenith Lab (Jiangsu) Co., Ltd
- EUDAMED SRN
- CN-MF-000026595
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 94af8415-7088-436d-a3e6-e8df79c85369 61 fields · synced Jul 11, 2026