Skip to content

smilla

by Schuchmann GmbH & Co. KG 3 variants

Ref 13 02 200

smilla (13 02 200) is an assistive ergonomic chair (EU MDR Class I; FDA Class I; FDA product code FRK, Chair, Examination And Treatment) made by Schuchmann GmbH & Co. KG, registered in EUDAMED on 17 Oct 2022 (Basic UDI-DI 4251040200004000130XXXX8J) and listed in FDA GUDID since 31 Aug 2026 (UDI-DI 04251040200356), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04251040200356 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4251040200004000130XXXX8J Basic UDI-DI 04251040200356UDI-DIDate17 Oct 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4251040200004000130XXXX8J registered 17 Oct 2022 Active
  • FDA GUDID UDI-DI 04251040200356 listed 31 Aug 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 4251040200004000130XXXX8J
  2. Listed FDA GUDID 04251040200356

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Assistive ergonomic chair, manually-adjusted
Model / reference
13 02 200 EUDAMED
size 2 GUDID
Primary DI / UDI-DI
04251040200356
Basic UDI-DI
4251040200004000130XXXX8J
Direct marketing DI
04251040200356
FDA product code
FRK
EMDN code
Y180918 Multifunctional chairs
GMDN term
Assistive ergonomic chair, manually-adjusted
Device class
Class I
Regulation number
880.6140
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
13 02 200
GUDID
size 2

Manufacturer details

EUDAMED SRN
DE-MF-000013435

Related devices

Category: Assistive ergonomic chair, electrically-adjusted

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL CHAIRS.

Other devices from Schuchmann GmbH & Co. KG

See all devices from Schuchmann GmbH & Co. KG →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)