Acumed 80-3640
by Acumed LLC
Ref 80-3640
Acumed 80-3640 is a Class I device made by Acumed LLC, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-10806378113871) and listed in FDA GUDID since 12 Aug 2019 (UDI-DI 10806378113871), active as of 7 Nov 2026.
Active
CE MDD
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/MDD EUDAMED | NumberB-10806378113871 10806378113871 | Date28 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10806378113871 | Date12 Aug 2019 | StatusListed |
Official records
- EUDAMED public site B-10806378113871
- AccessGUDID record 10806378113871
Across registries
- EUDAMED Basic UDI-DI B-10806378113871 registered 28 Oct 2026 Active
- FDA GUDID UDI-DI 10806378113871 listed 12 Aug 2019 Listed
Timeline
- Listed FDA GUDID 10806378113871
- Registered EUDAMED B-10806378113871
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Acumed
- Generic name
- General internal orthopaedic fixation system implantation kit
- Device name
- Instrument
- Model / reference
- 80-3640
- Primary DI / UDI-DI
- 10806378113871
- Basic UDI-DI
- B-10806378113871
- FDA product code
- FSM
- EMDN code
- L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
- GMDN term
- General internal orthopaedic fixation system implantation kit
- Device class
- Class I
- Regulation number
- 878.4800
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Spain
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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