← Back to catalogue
Calibration pack for Electrolyte Analyzer
EUDAMEDClass A (EU MDR)
Ref 90102Model Medical EasyLyte, AVL9180, CBS-300, CBS-400, CBS-500, CBS-301, CBS-401, CBS-501, CBS-3, CBS-4, CBS-5, KS Reagent Pack, KS-402 Reagent Pack
Identity
- Trade Name
- Calibration pack for Electrolyte Analyzer EUDAMED
- Device Name
- Calibration pack for Electrolyte Analyzer EUDAMED
- Model / Reference
- Medical EasyLyte, AVL9180, CBS-300, CBS-400, CBS-500, CBS-301, CBS-401, CBS-501, CBS-3, CBS-4, CBS-5, KS Reagent Pack, KS-402 Reagent Pack EUDAMED90102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337850129 EUDAMED
- Basic UDI-DI
- 697233785CalPack00749 EUDAMED
- EMDN Code
- W01010403 MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R. EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Calibration pack for Electrolyte Analyzer by B&E Bio-Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697233785CalPack00749 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B&E Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023256
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3f92f58c-8a65-44c2-b155-82b78d569bf7 61 fields · synced Jun 18, 2026