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Automatic Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref EBL9207003Model F 800Ref EBL9201001Model F 580Ref EBL9205003Model F 810Ref EBL9209003Model F 880Model F 880; F 810; F 800Ref EBL9201002Model F 560, F 580
Identity
- Trade Name
- Automatic Hematology Analyzer EUDAMED
- Device Name
- Automatic Hematology Analyzer EUDAMED
- Model / Reference
- F 800 EUDAMEDEBL9207003 EUDAMEDF 580 EUDAMEDEBL9201001 EUDAMEDF 810 EUDAMEDEBL9205003 EUDAMEDF 880 EUDAMEDEBL9209003 EUDAMEDF 880; F 810; F 800 EUDAMEDF 560, F 580 EUDAMEDEBL9201002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168350294 EUDAMED06972168355671 EUDAMED06972168355626 EUDAMED06972168350300 EUDAMED06972168357538 EUDAMED06972168357460 EUDAMED06972168357545 EUDAMED06972168357552 EUDAMED
- Basic UDI-DI
- B-06972168350294 EUDAMEDB-06972168355671 EUDAMEDB-06972168355626 EUDAMEDB-06972168350300 EUDAMED69721683520019R EUDAMED69721683522WV EUDAMED
- Direct Marketing DI
- 06972168357460 EUDAMED06972168357552 EUDAMED
- EMDN Code
- W0202010102 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr) EUDAMEDW0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Italy EUDAMEDSlovenia EUDAMEDGermany EUDAMEDTürkiye 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
New Device
No
EUDAMED
Automatic Hematology Analyzer by Maccura Medical Instrument Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06972168350294 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06972168350294 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (8)
- EUDAMED a42d3e47-9a6a-449b-87e6-988158b75ec9 61 fields · synced Oct 7, 2026
- EUDAMED bd0d94f9-bba5-434b-8b14-02cc49703ea3 61 fields · synced May 17, 2026
- EUDAMED 55fc6ab0-4207-4d5a-92fe-be8f8a009d99 61 fields · synced May 17, 2026
- EUDAMED b0ec1a07-7d09-4aed-94cc-d2fbf24dbcb9 61 fields · synced May 18, 2026
- EUDAMED b15b36e5-1427-48dc-91f1-ca413d2aef7a 61 fields · synced Jul 11, 2026
- EUDAMED a67a3cc3-ba1c-4459-a778-1b51bed9d44d 61 fields · synced Jul 18, 2026
- EUDAMED 340c63ac-48ea-4462-8e7c-73d347010ad5 61 fields · synced Jul 22, 2026
- EUDAMED 9654dda1-8e78-4f99-97d0-f853505c8fb8 61 fields · synced Jul 25, 2026