Imp Amb O2 2UNI Rid-Nt 1/4 E-Afn I-Man
Ref HKAMB001NTModel Medical gas equipments and distribution units for ambulances and emergency vehicles
Active
CE MDR
Valid until
14 Mar 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Overview
The IMP AMB O2 2UNI RID-NT 1/4 E-AFN I-MAN is a medical device designed for the administration of oxygen therapy in ambulances and emergency vehicles. It features a Class IIb rating, indicating its level of safety and efficacy. With a latest version number of 1 and a direct marketing identifier (DMI) of 08053687017023, this device is marketed under the trade name IMP AMB O2 2UNI RID-NT 1/4 E-AFN I-MAN. The IMEI/UDI UUID is 01KS5J3V5GPNZDVA41Z53GKS2B and has a multi-component ID of .
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 00022-A | Date20 Oct 2026 | StatusActive |
Certificates
- MDR 00022-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 20 Oct 2026
- Expires
- 14 Mar 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Medical gas equipments and distribution units for ambulances and emergency vehicles, HKAMB001NT
- Primary DI / UDI-DI
- 08053687017023
- Basic UDI-DI
- 805415412HK0EP
- Direct Marketing DI
- 08053687017023
- EMDN Code
- Z120309 Medical/medicinal gas pipeline systems and related accessories
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000023450
Other devices from Behringer S.R.L.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No