Conmed PRO6140
Ref PRO6140
Conmed PRO6140 is a pin-driving power tool attachment (EU MDD Class IIa; FDA Class I; FDA product code HWE, Instrument, Surgical, Orthopedic, Ac-Powered Motor and Accessory/Attachment) made by Conmed Corporation, registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI B-10845854036181) and listed in FDA GUDID since 14 Oct 2021 (UDI-DI 10845854036181), active as of 23 Oct 2026.
Active
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-10845854036181 10845854036181 | Date9 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10845854036181 | Date14 Oct 2021 | StatusListed |
Official records
- EUDAMED public site B-10845854036181
- AccessGUDID record 10845854036181
Across registries
- EUDAMED Basic UDI-DI B-10845854036181 registered 9 Apr 2026 Active
- FDA GUDID UDI-DI 10845854036181 listed 14 Oct 2021 Listed
Timeline
- Listed FDA GUDID 10845854036181
- Registered EUDAMED B-10845854036181
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Conmed
- Generic name
- Pin-driving power tool attachment
- Device name
- Orthopedic, Active, Attachment, Pin Driver, 1.8mm - 4.0mm
- Model / Ref / Catalog
- PRO6140
- Primary DI / UDI-DI
- 10845854036181
- Basic UDI-DI
- B-10845854036181
- FDA product code
- HWE
- EMDN code
- Z12130599 Motorised orthopaedic surgery system instruments - other
- GMDN term
- Pin-driving power tool attachment
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 878.4820
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
| Sterilise before use | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 10845854036181: EUDAMED states Yes, FDA GUDID states No.
Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
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