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Blood Gas Analyzer Test Card
EUDAMEDClass IVD General (EU MDR)
Ref W459-C7P4-E, W461-C7P4-E, W465-C7P4-E, W466-C7P4-E
Identity
- Device Name
- Blood Gas Analyzer Test Card EUDAMED
- Model / Reference
- W459-C7P4-E, W461-C7P4-E, W465-C7P4-E, W466-C7P4-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933289804288 EUDAMED
- Basic UDI-DI
- B-06933289804288 EUDAMED
- EMDN Code
- W0101060610 BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Blood Gas Analyzer Test Card by Guangzhou Wondfo Biotech 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-06933289804288 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED a107372f-b28c-492c-8464-c210453adfe4-1 61 fields · synced Jul 18, 2026
- EUDAMED a107372f-b28c-492c-8464-c210453adfe4-2 61 fields · synced Jul 18, 2026