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Auto 3-part Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref 012090401Model AC336
Identity
- Trade Name
- Auto 3-part Hematology Analyzer EUDAMED
- Device Name
- Auto 3-part Hematology Analyzer EUDAMED
- Model / Reference
- AC336 EUDAMED012090401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976578180717 EUDAMED
- Basic UDI-DI
- B-06976578180717 EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Auto 3-part Hematology Analyzer by Wheisman Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06976578180717 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wheisman Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000045463
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 916eede1-62a4-47b2-bf3a-60e5aba875f4 61 fields · synced Jun 19, 2026