MicroFrance® MCL55U
Ref MCL55U
MicroFrance® MCL55U is a device classified as Class IIa in the EU and Class I in the US made by Integra Microfrance, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-10381780105886) and listed in FDA GUDID since 10 Jan 2018 (UDI-DI 10381780105886), active as of 23 Oct 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-10381780105886 10381780105886 | Date1 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10381780105886 | Date10 Jan 2018 | StatusListed |
Official records
- EUDAMED public site B-10381780105886
- AccessGUDID record 10381780105886
Across registries
- EUDAMED Basic UDI-DI B-10381780105886 registered 1 Oct 2026 Active
- FDA GUDID UDI-DI 10381780105886 listed 10 Jan 2018 Listed
Timeline
- Listed FDA GUDID 10381780105886
- Registered EUDAMED B-10381780105886
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- MicroFrance®
- Generic name
- General-purpose endoscopic needle, reusable
- Device name
- Needle - Single Use
- Model / Ref / Catalog
- MCL55U
- Primary DI / UDI-DI
- 10381780105886
- Basic UDI-DI
- B-10381780105886
- FDA product code
- GDM
- EMDN code
- A010299 Biopsy needles and kits - other
- GMDN term
- General-purpose endoscopic needle, reusable
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 878.4800
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
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