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Calibrator for Automatic Hematology Analyzer (5-part)
EUDAMEDClass IVD General (EU MDR)
Ref 3003116Model 2.5 mLRef BF-6960CRPRef BCC-3600Ref BF-6900Ref BCC-3900Ref BF-6900CRPRef BCC-3960
Identity
- Trade Name
- Calibrator for Automatic Hematology Analyzer (5-part) EUDAMEDAutomatic Hematology Analyzer EUDAMED
- Device Name
- Calibrator for Automatic Hematology Analyzer (5-part) EUDAMEDAutomatic Hematology Analyzer EUDAMED
- Model / Reference
- 2.5 mL EUDAMED3003116 EUDAMEDBF-6960CRP EUDAMEDBCC-3600 EUDAMEDBF-6900 EUDAMEDBCC-3900 EUDAMEDBF-6900CRP EUDAMEDBCC-3960 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794505965 EUDAMED06925794514974 EUDAMED06925794504906 EUDAMED06925794576224 EUDAMED06925794514981 EUDAMED06925794576231 EUDAMED06925794588128 EUDAMED
- Basic UDI-DI
- B-06925794505965 EUDAMEDB-06925794514974 EUDAMEDB-06925794504906 EUDAMEDB-06925794576224 EUDAMEDB-06925794514981 EUDAMEDB-06925794576231 EUDAMEDB-06925794588128 EUDAMED
- EMDN Code
- W0103010507 WHOLE BLOOD CALIBRATORS EUDAMEDW0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
Calibrator for Automatic Hematology Analyzer (5-part) by Dirui Industrial 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-06925794505965 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED 169f37d3-9d98-499b-bda5-88adacb6f37d 61 fields · synced Sep 18, 2026
- EUDAMED 61576512-ddc5-4535-b00d-5804bb102d44 61 fields · synced Jul 8, 2026
- EUDAMED a44c8363-7198-4314-8a59-58eceee03c28 61 fields · synced Jul 9, 2026
- EUDAMED ce20bd52-f186-45e0-812a-0002105a8f01 61 fields · synced Jul 17, 2026
- EUDAMED 01751969-0bdf-41be-8f37-97d828c6e2af 61 fields · synced Jul 21, 2026
- EUDAMED 68d3603c-8b1e-49a0-ac43-330795c68500 61 fields · synced Jul 23, 2026
- EUDAMED 8a9d8916-21df-4bc9-a51c-e36286a62a7c 61 fields · synced Aug 1, 2026