Bel-Air hdpe Vent Tube 1.05mm
by Exmoor Plastics Limited United Kingdom EUDAMEDGUDID
Ref E59
Product code ETDEMDN Q03040101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-05060180256272 | Date13 Aug 2025 | StatusActive |
| United States | GUDID listing GUDID | Number05060180256272 | Date20 Sep 2018 | StatusListed |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Bel-Air hdpe Vent Tube 1.05mm EUDAMEDExmoor GUDID
- Generic Name
- Tympanostomy tube
- Device Name
- Aural Ventilation Tubes
- Model / Ref / Catalog
- E59, E.59
- Primary DI / UDI-DI
- 05060180256272
- Basic UDI-DI
- B-05060180256272
- FDA Product Code
- ETD
- EMDN Code
- Q03040101 Ear drainage and ventilation catheters and cannulas
- GMDN Term
- Tympanostomy tube
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 874.3880
- Market of Registration
- Ireland
- Commercial Distribution
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | E59 | E.59 |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- GB-MF-000025513
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Exmoor Plastics Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (16)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (2)
- EUDAMED 8f96bc1b-d129-4e22-a470-77f6ff6a37b5
- FDA UDI 736c8d2e-9613-450d-9275-e864d00dcd3b