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Control Devices 2108

by Control Devices, LLC

Ref 1531872200-6, 1531872700-8, 1531872800-1, 1531872200-8Model 1531872200, 1531872700, 1531872800

Control Devices 2108 (2108-25) is a device classified as Class IIb in the EU and Class I in the US made by Control Devices, LLC, registered in EUDAMED on 25 Jun 2025 (Basic UDI-DI B-00810051632071) and listed in FDA GUDID since 2 Jun 2025 (UDI-DI 00810051632071), active as of 22 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-00810051632071 Basic UDI-DI Date25 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810051632071 UDI-DI Date2 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00810051632071 registered 25 Jun 2025 Active
  • FDA GUDID UDI-DI 00810051632071 listed 2 Jun 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810051632071
  2. Registered EUDAMED B-00810051632071

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Control Devices
Generic name
Non-fixed medical gas cylinder regulator
Device name
Cga 870 Regulator
CGA 540 Regulator
Model / Ref / Catalog
1531872200, 1531872700, 1531872800, 1531872200-6, 1531872700-8, 1531872800-1, 1531872200-8, 2108, 2108-25
Primary DI / UDI-DI
00810051632071, 00810051632088, 00810051631500, 00810051631517, 00810051631357
Basic UDI-DI
B-00810051632071, B-00810051631500, B-00810051631517, B-00810051632088
FDA product code
CAN
EMDN code
A030104 Flow regulators
GMDN term
Non-fixed medical gas cylinder regulator
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
868.2700
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

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

Related devices

Category: Non-fixed medical gas cylinder regulator

Similar devices in this category

Other devices filed under FLOW REGULATORS.

Other devices from Control Devices, LLC

See all devices from Control Devices, LLC →

Properties

  • Administering medicine
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)