28272GM
Ref 28272GM
28272GM is a surgical instrument assist arm system (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551001837UJ) and listed in FDA GUDID since 23 Feb 2019 (UDI-DI 04048551321553), active as of 22 Oct 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 | Number4048551001837UJ 04048551321553 | Date19 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04048551321553 | Date23 Feb 2019 | StatusListed |
Official records
- EUDAMED public site 4048551001837UJ
- AccessGUDID record 04048551321553
Across registries
- EUDAMED Basic UDI-DI 4048551001837UJ registered 19 May 2026 Active
- FDA GUDID UDI-DI 04048551321553 listed 23 Feb 2019 Listed
Timeline
- Listed FDA GUDID 04048551321553
- Registered EUDAMED 4048551001837UJ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Surgical instrument assist arm system, manually-adjusted
- Device name
- Exoscope holding systems
- Model / reference
- 28272GM
- Primary DI / UDI-DI
- 04048551321553
- Basic UDI-DI
- 4048551001837UJ
- FDA product code
- EPT
- EMDN code
- Z1201118099 Instruments for operative microscopy - hardware accessories - other
- GMDN term
- Surgical instrument assist arm system, manually-adjusted
- Device class
- Class I
- Regulation number
- 878.4700
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
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