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Calcium Reagent Kit（cresolphthalein Complexone Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3003010Model R1: 4x20mL, R2: 4x20mL, Calibration sample: 2mLRef 3021182Model R1: 2x50mL, R2: 2x50mL, Calibration sample: 2mLRef 3016527Ref 3023208Ref 3016551
Identity
- Trade Name
- CALCIUM REAGENT KIT（CRESOLPHTHALEIN COMPLEXONE METHOD） EUDAMED
- Device Name
- CALCIUM REAGENT KIT（CRESOLPHTHALEIN COMPLEXONE METHOD） EUDAMED
- Model / Reference
- R1: 4x20mL, R2: 4x20mL, Calibration sample: 2mL EUDAMED3003010 EUDAMEDR1: 2x50mL, R2: 2x50mL, Calibration sample: 2mL EUDAMED3021182 EUDAMED3016527 EUDAMED3023208 EUDAMED3016551 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260377 EUDAMED06942202260353 EUDAMED06942202260360 EUDAMED06942202213496 EUDAMED06942202260346 EUDAMED
- Basic UDI-DI
- B-06942202260377 EUDAMEDB-06942202260353 EUDAMEDB-06942202260360 EUDAMEDB-06942202213496 EUDAMEDB-06942202260346 EUDAMED
- EMDN Code
- W01010299 SUBSTRATES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Calcium Reagent Kit（cresolphthalein Complexone Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06942202260377 | 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 (5)
- EUDAMED aec90e7f-9c5e-4e5b-a804-529feefc8288 61 fields · synced Jul 27, 2026
- EUDAMED f25b7539-9508-4567-8308-574fb749b12b 61 fields · synced Jul 10, 2026
- EUDAMED 3eb55cb3-00e6-455e-a814-26b7a89d2edd 61 fields · synced Jul 16, 2026
- EUDAMED b7e70327-29f0-415b-95c4-8862f2e96d0f 61 fields · synced Jul 26, 2026
- EUDAMED ad6d25d4-e477-49a5-b250-5b77bbb79032 61 fields · synced Jul 27, 2026