Identity
- Device Name
- MC-04 EUDAMED
- Model / Reference
- MC-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976374330385 EUDAMED
- Basic UDI-DI
- 697637433MC-04GF 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
Category: General-purpose centrifuge IVD
Mc-04 by Zenith Lab (Jiangsu) Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697637433MC-04GF | 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 8c4c5d50-e3f3-4135-8bbe-60e242f5b746 61 fields · synced Jul 10, 2026