Blood Gas Testing Cartridge
by Wuhan Easydiagnosis Biomedicine Co., Ltd. EUDAMED
Active
Ref W-PT5-2-150Model PT3,PT4L,PT4H,PT5,PT6E,PT6,PT8,PT9L,PT9G,PT10
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697372013BGBG001B4 | Date29 May 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 2055510-1 Issued
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 1 Jul 2025
- Expires
- 21 Mar 2029
Specification
- Device Name
- Blood Gas Testing Cartridge
- Model / Reference
- PT3, PT4L, PT4H, PT5, PT6E, PT6, PT8, PT9L, PT9G, PT10, W-PT5-2-150
- Primary DI / UDI-DI
- 06978896414833
- Basic UDI-DI
- 697372013BGBG001B4
- EMDN Code
- W0101060610 Blood gas incl. electrolytes / metabolites - multi use cassette
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000019908
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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Properties
Show properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No