Hamilton-T1 1610060
Ref 1610060
Hamilton-T1 1610060 is a device classified as Class IIb in the EU and Class II in the US made by Hamilton Medical AG, registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 76300028PN16100605C) and listed in FDA GUDID since 26 Jan 2022 (UDI-DI 07630002813532), active as of 9 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number76300028PN16100605C 07630002813532 | Date2 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07630002813532 | Date26 Jan 2022 | StatusListed |
Official records
- EUDAMED public site 76300028PN16100605C
- AccessGUDID record 07630002813532
Across registries
- EUDAMED Basic UDI-DI 76300028PN16100605C registered 2 Sep 2026 Active
- FDA GUDID UDI-DI 07630002813532 listed 26 Jan 2022 Listed
Timeline
- Listed FDA GUDID 07630002813532
- Registered EUDAMED 76300028PN16100605C
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Hamilton-T1
- Generic name
- Neonatal/adult intensive-care ventilator
- Model / Ref / Catalog
- 1610060
- Primary DI / UDI-DI
- 07630002813532
- Basic UDI-DI
- 76300028PN16100605C
- FDA product code
- CBK, BZR, DQA
- EMDN code
- R9099 Respiratory and anaesthesia devices - other
- GMDN term
- Neonatal/adult intensive-care ventilator
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 868.5895, 868.5330, 870.2700
- EU registration type
- Standard device
- EU market of registration
- Austria
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIb | Class II |
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