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Blood Gas Testing Cartridge
EUDAMEDClass C (EU MDR)
Ref W-PT6E-150Model PT3,PT4L,PT4H,PT5,PT6E,PT6,PT8,PT9L,PT9G,PT10
Identity
- Device Name
- Blood Gas Testing Cartridge EUDAMED
- Model / Reference
- PT3,PT4L,PT4H,PT5,PT6E,PT6,PT8,PT9L,PT9G,PT10 EUDAMEDW-PT6E-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973720135298 EUDAMED
- Basic UDI-DI
- 697372013BGBG001B4 EUDAMED
- EMDN Code
- W0101060699 BLOOD GAS ELECTRODES OR CASSETTE POC - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Blood Gas Testing Cartridge by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class C — 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 | 697372013BGBG001B4 | Class C | 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 (1)
- EUDAMED 31ce31b7-58d6-41df-aa8d-d8a6f653e751 61 fields · synced Jul 8, 2026