Calibration Gas
by Sentec AG
Ref 103149
Calibration Gas (103149) is a Class I device made by SenTec AG, registered in EUDAMED on 15 Nov 2021 (Basic UDI-DI 764012188GAS-08127M), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764012188GAS-08127M | Date15 Nov 2021 | StatusActive |
Official records
- EUDAMED public site 764012188GAS-08127M
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Service Gas
- Model / reference
- 103149
- Primary DI / UDI-DI
- 17640121880985, 27640121880982
- Basic UDI-DI
- 764012188GAS-08127M
- Direct marketing DI
- 1764012188098527640121880982
- EMDN code
- Z1203020405 Transcutaneous po2/pco2 monitors
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000008058
- Authorised representative
- Sentec GmbH DE-AR-000007618
Similar devices in this category
Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.
- ULTRAMAXO2 R221P11-002 by Maxtec, Inc.
- SpO2 Draeger Infant Band, 24 pcs. MS16447 by Draeger Medical Systems, Inc.
- INVOS PMAC71DOC by Covidien LP
- FINGERTIP PULSE OXIMETER with 9590 RED, OXIMETER 8712-002 by Nonin Medical, Inc.
- NeoStatCO2 10-55373 by Mercury Medical Enterprises, LLC
- Pulse Oximeter HandyOxi500 by Shenzhen Envisen Industry Co., Ltd.
- PO6L by Andon Health Co., Ltd.
- Finger Pulse Oximeter 170 by Shenzhen Fitfaith Technology Co., Ltd
- CONTEC CMS50I by Contec Medical Systems Co., Ltd.
- Rad-5® Handheld signal extraction pulse oximeter 9198 by MASIMO CORPORATION