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Copper Reagent Kit (PAESA Chromogenic Agent Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3011909Model R1: 1x30mL, R2: 1x10mL,Calibration sample: 1x1mL, Control: 2x1mLRef 3013031Model R1: 1x30mL, R2: 1x10mLRef 3011769Ref 3021151Model R1: 1x30mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL
Identity
- Trade Name
- Copper Reagent Kit (PAESA Chromogenic Agent Assay) EUDAMED
- Device Name
- Copper Reagent Kit (PAESA Chromogenic Agent Assay) EUDAMED
- Model / Reference
- R1: 1x30mL, R2: 1x10mL,Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3011909 EUDAMEDR1: 1x30mL, R2: 1x10mL EUDAMED3013031 EUDAMED3011769 EUDAMEDR1: 1x30mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3021151 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246920 EUDAMED06942202260506 EUDAMED06942202246913 EUDAMED06942202260490 EUDAMED
- Basic UDI-DI
- B-06942202246920 EUDAMEDB-06942202260506 EUDAMEDB-06942202246913 EUDAMEDB-06942202260490 EUDAMED
- EMDN Code
- W01010206 COPPER 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
Category: Copper IVD, reagent
Copper Reagent Kit (PAESA Chromogenic Agent Assay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Copper IVD, reagent.
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- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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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-06942202246920 | 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 (4)
- EUDAMED 7ebe8a53-e2dc-4c55-b3b1-7ee3056eb5c0 61 fields · synced Jul 26, 2026
- EUDAMED 901dff8f-7b99-4733-b826-ef6ac521b714 61 fields · synced May 17, 2026
- EUDAMED b3de09b6-2384-4e9c-803e-a9fbbf5774a6 61 fields · synced May 18, 2026
- EUDAMED 08bd6c35-c271-42bf-af0a-78a35e626b45 61 fields · synced Jul 20, 2026