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R82 Scallop 3

by R82 a/S 2 variants

R82 Scallop 3 (991051-3R43F) is a Class I device made by R82 a/S, listed in FDA GUDID since 12 Oct 2022 (UDI-DI 05707292621054), not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05707292621054 UDI-DI Date12 Oct 2022ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
R82
Generic name
Assistive ergonomic chair, manually-adjusted
Model / Ref / Catalog
Scallop 3, 991051-3R43F
Primary DI / UDI-DI
05707292621054
FDA product code
INN
GMDN term
Assistive ergonomic chair, manually-adjusted
Device class
Class I
Regulation number
890.3100
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code INN (CHAIR, ADJUSTABLE, MECHANICAL).

Other devices from R82 a/S

See all devices from R82 a/S →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)