Primediair ® -VO1
by Primed Halberstadt Medizintechnik GmbH Germany EUDAMED
Ref 21066, 20485, 20482, 21063, 20497, 21065Model HME mit O2-Anschluss, HME ohne O2-Anschluss unsteril, HME ohne O2-Anschluss
EMDN R040201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42502032PRI0244N | Date12 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Primediair ® -VO1Primediair ® -KanPrimediair ® -KasPrimediair ® -VO2Primediair ® -Dual
- Model / Reference
- HME mit O2-Anschluss, 21066, HME ohne O2-Anschluss unsteril, 20485, HME ohne O2-Anschluss, 20482, 21063, 20497, 21065
- Primary DI / UDI-DI
- 04250203201056, 04250203210683, 04250203225267, 04250203201032, 04250203210713, 04250203201049
- Basic UDI-DI
- 42502032PRI0244N, 42502032PRI0224J, 42502032PRI0234L
- EMDN Code
- R040201 Tracheostomy humidifiers
- Device Class
- Class IIaClass I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000004967
Other devices from Primed Halberstadt Medizintechnik GmbH
See all devices from Primed Halberstadt Medizintechnik GmbH →
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: 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
Sources (6)
- EUDAMED 82fb02fd-c61e-4f73-83f7-4d330aa2e37e
- EUDAMED 04250203210683|42502032PRI0224J
- EUDAMED 04250203225267|42502032PRI0234L
- EUDAMED 04250203201032|42502032PRI0244N
- EUDAMED 04250203210713|42502032PRI0244N
- EUDAMED 04250203201049|42502032PRI0244N