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Hematology Reagent Kit
EUDAMEDClass A (EU MDR)
Ref 12600777Model Hematology Reagent Kit
Identity
- Trade Name
- Hematology Reagent Kit EUDAMED
- Device Name
- Hematology Reagent Kit EUDAMED
- Model / Reference
- Hematology Reagent Kit EUDAMED12600777 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175046249 EUDAMED
- Basic UDI-DI
- 6934175002B0030NY EUDAMED
- Direct Marketing DI
- 06934175046249 EUDAMED
- EMDN Code
- W0103010103 COMPLETE CELL COUNT EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hematology Reagent Kit by Changsha Sinocare Inc. — 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 | 6934175002B0030NY | Class A | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 204aeedb-5507-48be-8189-a398549e5e9d 61 fields · synced Jun 19, 2026