Rad-97 95004
Ref 95004
Rad-97 95004 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 084399700000Z0T3A01V001EP) with CE/MDR certificate 28620149254-03 valid until 29 Apr 2028 and listed in FDA GUDID since 8 Oct 2021 (UDI-DI 00843997016612), active as of 25 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 | Number084399700000Z0T3A01V001EP 00843997016612 | Date4 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00843997016612 | Date8 Oct 2021 | StatusListed |
Official records
- EUDAMED public site 084399700000Z0T3A01V001EP
- AccessGUDID record 00843997016612
Across registries
- EUDAMED Basic UDI-DI 084399700000Z0T3A01V001EP registered 4 Jun 2026 Active
- FDA GUDID UDI-DI 00843997016612 listed 8 Oct 2021 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 00843997016612
- Certificate issued EUDAMED 28620149254-03
- Registered EUDAMED 084399700000Z0T3A01V001EP
- Certificate expires EUDAMED 28620149254-03
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Rad-97 Home Use with noninvasive blood pressure EUDAMEDRad-97 GUDID
- Generic name
- Pulse Co-oximeter
- Model / reference
- 95004
- Primary DI / UDI-DI
- 00843997016612
- Basic UDI-DI
- 084399700000Z0T3A01V001EP
- Direct marketing DI
- 00843997013703
- 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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