Jaeger 36-TDX1043
Jaeger 36-TDX1043 is a Class II device made by Jaeger Medical GmbH, cleared under FDA 510(k) K031102 on 1 Dec 2003 and listed in FDA GUDID since 2 Jun 2025 (UDI-DI 14250892908103), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number14250892908103 | Date2 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031102 | Date1 Dec 2003 | StatusActive |
Official records
- AccessGUDID record 14250892908103
- FDA 510(k) database K031102
Across registries
- FDA 510(k) K031102 decided 1 Dec 2003 Active
- FDA GUDID UDI-DI 14250892908103 listed 2 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K031102
- Listed FDA GUDID 14250892908103
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Jaeger
- Generic name
- Diagnostic spirometer, professional
- Model / Ref / Catalog
- 36-TDX1043
- Primary DI / UDI-DI
- 14250892908103
- 510(k) Number
- FDA product code
- BZG
- GMDN term
- Diagnostic spirometer, professional
- Device class
- Class II
- Regulation number
- 868.1840
- GUDID distribution status
- In Commercial Distribution
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