EVA SB Hose, 19f, 180cm w/Cuff, 22F*2
Ref AT0033Model (Q) Tubing
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number04710810089749 | Date5 Mar 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number471081008NNQ38F 04710810089749 | Date17 Jun 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Inspiratory/expiratory limb respiratory tubing, single-use
- Device Name
- EVA Hose / Smooth
- Model / Ref / Catalog
- (Q) Tubing, AT0033, 38072
- Primary DI / UDI-DI
- 04710810089749
- Basic UDI-DI
- 471081008NNQ38F
- 510(k) Number
- FDA Product Code
- BZD
- EMDN Code
- R02010101 Breathing circuits, w/o water trap
- GMDN Term
- Inspiratory/expiratory limb respiratory tubing, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 868.5905
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | (Q) Tubing AT0033 | 38072 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- TW-MF-000022411
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from GaleMed Corporation
Properties
Other properties (19)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No