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i-Check Cartridge
EUDAMEDClass IVD General (EU MDR)
Ref ELE-ⅢRef ELE-ⅡRef ELE-ⅠRef BE3Model BE3,ELE-I, ELE-Ⅱ, ELE-Ⅲ, BG3, BG7, BG8, BG9-Ⅰ, BG9-Ⅱ, BG10-Ⅰ, BG10-ⅡRef BG8Ref BG10-Ⅱ
Identity
- Device Name
- i-Check Cartridge EUDAMED
- Model / Reference
- ELE-Ⅲ EUDAMEDELE-Ⅱ EUDAMEDELE-Ⅰ EUDAMEDBE3,ELE-I, ELE-Ⅱ, ELE-Ⅲ, BG3, BG7, BG8, BG9-Ⅰ, BG9-Ⅱ, BG10-Ⅰ, BG10-Ⅱ EUDAMEDBE3 EUDAMEDBG8 EUDAMEDBG10-Ⅱ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337858033 EUDAMED06972337858026 EUDAMED06972337858019 EUDAMED16972337852199 EUDAMED06972337858040 EUDAMED06972337858002 EUDAMED
- Basic UDI-DI
- B-06972337858033 EUDAMEDB-06972337858026 EUDAMEDB-06972337858019 EUDAMEDB-16972337852199 EUDAMEDB-06972337858040 EUDAMEDB-06972337858002 EUDAMED
- EMDN Code
- W0101060610 BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE EUDAMEDW0201040185 BLOOD GAS ANALYSERS - CONSUMABLES 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
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
i-Check Cartridge by B&E Bio-Technology 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-06972337858033 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- B&E Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023256
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (6)
- EUDAMED 28b4f244-8fa1-4fa0-82fc-1bf406d3fceb 61 fields · synced Jul 26, 2026
- EUDAMED ae0de386-9289-4f3f-82e0-ef35887ff237 61 fields · synced May 17, 2026
- EUDAMED a291917a-4a6f-4b39-b18a-5e8ad6884aca 61 fields · synced May 17, 2026
- EUDAMED 9be0174b-98a4-4743-9050-ad4195358820 61 fields · synced May 18, 2026
- EUDAMED 7fc2b126-b3bb-44a4-980b-3389d3b7464c 61 fields · synced May 18, 2026
- EUDAMED ad7ebebc-24e8-46c6-8684-0220c4d82299 61 fields · synced May 18, 2026