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ORIGO Control Unit

by Bien-Air Surgery SA

Ref 1601048

ORIGO Control Unit (1601048) is a device classified as Class IIa in the EU and Class II in the US made by Bien-Air Surgery SA, registered in EUDAMED on 26 Aug 2023 (Basic UDI-DI 76300555_001_EQ) and listed in FDA GUDID since 30 Jan 2023 (UDI-DI 07630055511744), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300555_001_EQ Basic UDI-DI 07630055511744UDI-DIDate26 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07630055511744 UDI-DI Date30 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76300555_001_EQ registered 26 Aug 2023 Active
  • FDA GUDID UDI-DI 07630055511744 listed 30 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630055511744
  2. Registered EUDAMED 76300555_001_EQ

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  • Withdrawn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
Surgical power tool system control unit, line-powered
Model / Ref / Catalog
1601048, 1601048-001
Primary DI / UDI-DI
07630055511744
Basic UDI-DI
76300555_001_EQ
Direct marketing DI
07630055511744
FDA product code
HBC, HBE, NLY, ERL, EQJ
EMDN code
Z12019099 Various instruments for general and multidisciplinary surgery - other
GMDN term
Surgical power tool system control unit, line-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4360, 882.4310, 874.4140, 874.4250
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
CH-MF-000016376
Authorised representative
Bien-Air Europe Sàrl FR-AR-000011942

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER.

Other devices from Bien-Air Surgery SA

See all devices from Bien-Air Surgery SA →

Properties

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