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Copper Colorimetric Test with Dibromo-PAESA
EUDAMEDClass IVD General (EU MDR)
Ref D-617 002Ref D-617 001
Identity
- Trade Name
- Copper Colorimetric Test with Dibromo-PAESA EUDAMED
- Device Name
- Copper Colorimetric Test with Dibromo-PAESA EUDAMED
- Model / Reference
- D-617 002 EUDAMEDD-617 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182712532 EUDAMED62230182712464 EUDAMED
- Basic UDI-DI
- B-62230182712532 EUDAMEDB-62230182712464 EUDAMED
- EMDN Code
- W01010206 COPPER 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
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 Colorimetric Test with Dibromo-PAESA by Kalians Corporation — 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
- Copper - Single reagent — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
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- Miedź 5 x 10 ml — BioMaxima Spółka Akcyjna · Class B
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-62230182712532 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 5ff4f396-f859-4531-a382-6cb5a0438627 61 fields · synced Jul 20, 2026
- EUDAMED 05473930-5e04-4514-a720-ffacdaeb577a 61 fields · synced May 18, 2026