CO2 Sidestream Module
by Beijing Kingst Commercial & Trade Co., Ltd. EUDAMEDGUDID
Active
Ref Capno-S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06974774500063 | Date2 Apr 2026 | StatusIn distribution |
| European Union | CE/MDD EUDAMED | NumberB-06974774500063 | Date18 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- CO2 Sidestream Module EUDAMEDKingst GUDID
- Generic Name
- Carbon dioxide sensor/cable
- Device Name
- CO2 modulesMultigas Analyzer
- Model / Reference
- Capno-S
- Primary DI / UDI-DI
- 06974774500063
- Basic UDI-DI
- B-06974774500063, 697477450E001HD
- Direct Marketing DI
- 06974774500063
- 510(k) Number
- FDA Product Code
- CCK
- EMDN Code
- Z12030299, Z1203020299
- GMDN Term
- Carbon dioxide sensor/cable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 868.1400
- Market of Registration
- SpainNetherlands
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000025530
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No