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Blood Gas, Electrolyte, Metabolite Control
EUDAMEDClass IVD General (EU MDR)
Ref W-QP-C-123Model Level 1, 1 ampuls Level 2, 1 ampuls Level 3, 1 ampulsRef W-QP-B-3Model Level 3, 5 ampulsRef W-QP-A-2Model Level 2, 30 ampulsRef W-QP-B-1Model Level 1, 5 ampulsRef W-QP-A-123Model Level 1, 10 ampuls Level 2, 10 ampuls Level 3, 10 ampulsRef R-QP-A-1Model Level 1, 30 ampulsRef R-QP-A-2Ref R-QP-B-2Model Level 2, 5 ampuls
Identity
- Trade Name
- Blood Gas, Electrolyte, Metabolite Control EUDAMED"Blood Gas, Electrolyte, Metabolite Control" EUDAMED
- Device Name
- Blood Gas, Electrolyte, Metabolite Control EUDAMED
- Model / Reference
- Level 1, 1 ampuls Level 2, 1 ampuls Level 3, 1 ampuls EUDAMEDW-QP-C-123 EUDAMEDLevel 3, 5 ampuls EUDAMEDW-QP-B-3 EUDAMEDLevel 2, 30 ampuls EUDAMEDW-QP-A-2 EUDAMEDLevel 1, 5 ampuls EUDAMEDW-QP-B-1 EUDAMEDLevel 1, 10 ampuls Level 2, 10 ampuls Level 3, 10 ampuls EUDAMEDW-QP-A-123 EUDAMEDLevel 1, 30 ampuls EUDAMEDR-QP-A-1 EUDAMEDR-QP-A-2 EUDAMEDLevel 2, 5 ampuls EUDAMEDR-QP-B-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896416295 EUDAMED06978896416288 EUDAMED06978896416233 EUDAMED06978896416264 EUDAMED06978896416257 EUDAMED06978896416332 EUDAMED06978896416349 EUDAMED06978896416318 EUDAMED
- Basic UDI-DI
- B-06978896416295 EUDAMEDB-06978896416288 EUDAMEDB-06978896416233 EUDAMEDB-06978896416264 EUDAMEDB-06978896416257 EUDAMEDB-06978896416332 EUDAMEDB-06978896416349 EUDAMEDB-06978896416318 EUDAMED
- EMDN Code
- W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMEDW0101050199 MULTICOMPONENT CONTROLS (CC) - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
The Blood Gas, Electrolyte, Metabolite Control device is a medical device used for monitoring and analyzing the levels of various substances in the body. It is designed to be reusable and has undergone thorough testing to ensure its safety and efficacy.
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-06978896416295 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (8)
- EUDAMED 355881a8-d6e3-41d0-bb53-aade60211372 61 fields · synced Oct 6, 2026
- EUDAMED 7bfc6379-2f9e-4745-8e7a-66bf5745d22a 61 fields · synced May 18, 2026
- EUDAMED 9ca84e63-bcb3-47ae-9bad-2f1df15eb333 61 fields · synced May 18, 2026
- EUDAMED a3f73005-0d08-447b-8eed-010521f6d390 61 fields · synced Jul 9, 2026
- EUDAMED 362849d8-e0fb-4c6f-a2cf-e25292afb12a 61 fields · synced Jul 13, 2026
- EUDAMED 8d33907f-fd35-4116-8a4c-f37722d4fb5a 61 fields · synced Jul 13, 2026
- EUDAMED e71cfc99-b227-408d-874b-4d83d80d0c61 61 fields · synced Jul 21, 2026
- EUDAMED a2c71596-b7ae-4def-851f-986a23b42862 61 fields · synced Jul 24, 2026