Z1203019080
Ref 100627CModel DreamStation 4G Cell Modem w/ Ox, EU
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-00606959080577 00606959080577 | Date2 Sep 2026 | StatusActive |
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- Withdrawn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/MDD Active
Specification
- Model / Reference
- DreamStation 4G Cell Modem w/ Ox, EU, 100627C
- Primary DI / UDI-DI
- 00606959080577
- Basic UDI-DI
- B-00606959080577
- EMDN Code
- Z1203019080 Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000002301
- Authorised representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Other devices from Respironics Inc.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No