Respimer
by Laboratoire de la Mer 8 variants
Ref OH2510100Model LABMER-001/D-02
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number356430LABMER-001/D-GS 03564300034839 | Date13 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Isotonic seawater solution for nasal cavities cleansing in Power Pouch continuous spray (RDOTC92001)
- Model / Reference
- LABMER-001/D-02, OH2510100
- Primary DI / UDI-DI
- 03564300034839
- Basic UDI-DI
- 356430LABMER-001/D-GS
- Direct Marketing DI
- 03564300034839
- EMDN Code
- Q030103 Nasal irrigation solutions
- Device Class
- Class IIa
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000009050
Other devices from Laboratoire de la Mer
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No