Rad-97 9799
Ref 9799
Rad-97 9799 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 5 Jun 2026 (Basic UDI-DI 084399700000Z0T3A01V002ER) with CE/MDR certificate 28620149254-03 valid until 29 Apr 2028 and listed in FDA GUDID since 16 Jul 2020 (UDI-DI 00843997012782), active as of 22 Oct 2026.
Active
CE MDR
Valid until
29 Apr 2028
FDA recalls
Not checked
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number084399700000Z0T3A01V002ER 00843997012782 | Date5 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00843997012782 | Date16 Jul 2020 | StatusListed |
Official records
- EUDAMED public site 084399700000Z0T3A01V002ER
- AccessGUDID record 00843997012782
Across registries
- EUDAMED Basic UDI-DI 084399700000Z0T3A01V002ER registered 5 Jun 2026 Active
- FDA GUDID UDI-DI 00843997012782 listed 16 Jul 2020 Listed
Certificates
- 28620149254-03 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 18 Dec 2023
- Expires
- 29 Apr 2028
- Reason
- Add device or group
- 28620149254-03 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 18 Dec 2023
- Expires
- 29 Apr 2028
- Reason
- Add device or group
Timeline
- Listed FDA GUDID 00843997012782
- Certificate issued EUDAMED 28620149254-03
- Registered EUDAMED 084399700000Z0T3A01V002ER
- Certificate expires EUDAMED 28620149254-03
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Rad-97 with NomoLine Capnography EUDAMEDRad-97 GUDID
- Generic name
- Pulse Co-oximeter
- Model / Ref / Catalog
- 9799
- Primary DI / UDI-DI
- 00843997012782
- Basic UDI-DI
- 084399700000Z0T3A01V002ER
- Direct marketing DI
- 00843997013710
- FDA product code
- MWI
- EMDN code
- Z1203020202 Transportable/portable multi–parameter patient monitors
- GMDN term
- Pulse Co-oximeter
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 870.2300
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIb | Class II |
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