← Back to catalogue
Blood gas/Electrolyte analyzer
EUDAMEDClass A (EU MDR)
Ref BG-800AModel BG-800Model BG-800A、BG-800B、BG-800、BG-800AQ、BG-800BQ、BG-8000、BG-800ERef BG-800AQRef Gaslite80Model Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80ERef BG-800BQRef Gaslite80QRef BG-800BRef BG-800E
Identity
- Device Name
- Blood gas/Electrolyte analyzer EUDAMEDBlood Gas & Electrolyte Analyzer EUDAMED
- Model / Reference
- BG-800 EUDAMEDBG-800A EUDAMEDBG-800A、BG-800B、BG-800、BG-800AQ、BG-800BQ、BG-8000、BG-800E EUDAMEDBG-800AQ EUDAMEDGaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E EUDAMEDGaslite80 EUDAMEDBG-800BQ EUDAMEDGaslite80Q EUDAMEDBG-800B EUDAMEDBG-800E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947929500416 EUDAMED06947929500478 EUDAMED06947929500461 EUDAMED06947929500492 EUDAMED06947929500522 EUDAMED06947929500430 EUDAMED06947929500140 EUDAMED06947929500454 EUDAMED
- Basic UDI-DI
- 69479295BG-800LB EUDAMED69479295Gaslite80Z2 EUDAMED
- EMDN Code
- W0201040102 BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMEDEUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Blood gas/Electrolyte analyzer by Meizhou Cornley Hi-Tech 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 | 69479295BG-800LB | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meizhou Cornley Hi-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025014
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (9)
- EUDAMED 9f937a92-d159-43fd-a870-0e6afcbd55c9 61 fields · synced Jul 29, 2026
- EUDAMED bb8d9da2-c4c9-4f73-b4e8-4b9e8cfe2cbc 61 fields · synced Jul 9, 2026
- EUDAMED 27f63d02-98f6-408c-84db-50e26eebdb7a 61 fields · synced Jul 10, 2026
- EUDAMED c69aa663-ae3f-4273-ae4c-0a111c8f1c69 61 fields · synced Jul 14, 2026
- EUDAMED 02d92587-25d6-484d-b811-eb110614db63 61 fields · synced Jul 16, 2026
- EUDAMED 67f4e40c-bead-4e70-ad20-260fcb52c13c 61 fields · synced Jul 19, 2026
- EUDAMED cba0887a-ac1c-44c7-8579-416ed49db4a5 61 fields · synced Jul 27, 2026
- EUDAMED f640c054-f19d-4ce4-96f5-dac4c41e1c74 61 fields · synced Jul 27, 2026
- EUDAMED 5abdda91-96e6-4224-b917-1238798bca08 61 fields · synced Jul 29, 2026