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Mission 3D Hematology Reagent (Cyto-Lyser)
EUDAMEDClass A (EU MDR)
Ref C121-9021-201
Identity
- Trade Name
- Mission 3D Hematology Reagent (Cyto-Lyser) EUDAMED
- Device Name
- 3D Hematology Reagent EUDAMED
- Model / Reference
- C121-9021-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921756496487 EUDAMED
- Basic UDI-DI
- 6921756499990030WW EUDAMED
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - OTHER 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
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
Mission 3D Hematology Reagent (Cyto-Lyser) by Acon Biotech (Hangzhou) 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 | 6921756499990030WW | Class A | Active |
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Manufacturer
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000006977
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 3fd64254-4c59-436b-b3cd-607b3505068a 61 fields · synced Jun 19, 2026