Strados Labs SWD1
by Strados Labs
Strados Labs SWD1 (810-00007) is a Class II device made by Strados Labs, listed in FDA GUDID since 2 Dec 2022 (UDI-DI 00850043625018), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850043625018 | Date2 Dec 2022 | StatusListed |
Official records
- AccessGUDID record 00850043625018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Strados Labs
- Generic name
- Cough ambulatory recording system
- Model / Ref / Catalog
- SWD1, 810-00007
- Primary DI / UDI-DI
- 00850043625018
- FDA product code
- DSH
- GMDN term
- Cough ambulatory recording system
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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