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Complete Control System Gen2

by Coapt, LLC

Ref N1

Complete Control System Gen2 (N1) is a device of GMDN type myoelectric hand prosthesis (EU MDR Class I; FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Coapt, LLC, registered in EUDAMED on 10 Nov 2021 (Basic UDI-DI ++B618N18Z), cleared under FDA 510(k) K191083 on 24 May 2019 (1 earlier submission) and listed in FDA GUDID since 12 Jun 2019 (UDI-DI B618N1), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191083↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B618N18Z Basic UDI-DI B618N1UDI-DIDate10 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID NumberB618N1 UDI-DI Date12 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK191083 Date24 May 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++B618N18Z registered 10 Nov 2021 Active
  • FDA 510(k) K191083 decided 24 May 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI B618N1 listed 12 Jun 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K162891
  2. Cleared FDA 510(k) K191083
  3. Listed FDA GUDID B618N1
  4. Registered EUDAMED ++B618N18Z

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Myoelectric hand prosthesis
Model / reference
N1 EUDAMED
1 GUDID
Primary DI / UDI-DI
B618N1
Basic UDI-DI
++B618N18Z
510(k) Number
FDA product code
GXY
EMDN code
Y061899, Z12100492
GMDN term
Myoelectric hand prosthesis
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
N1
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000003759
Authorised representative
Fillauer Europe AB SE-AR-000002627

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHY INSTRUMENTS.

Other devices from Coapt, LLC

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)