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Osmolarity High Control Solution 100013

by Tearlab Corporation

Ref 100013

Osmolarity High Control Solution 100013 is a device classified as IVD General made by Tearlab Corporation, registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI B-00853539002058) and listed in FDA GUDID since 5 Jan 2024 (UDI-DI 00853539002058), active as of 22 Oct 2026.

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

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00853539002058 Basic UDI-DI 00853539002058UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00853539002058 UDI-DI Date5 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00853539002058 registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 00853539002058 listed 5 Jan 2024 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00853539002058
  2. Registered EUDAMED B-00853539002058

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Osmolarity Control Solutions (High) EUDAMED
Osmolarity High Control Solution GUDID
Generic name
Osmolality IVD, control
Model / reference
100013
Primary DI / UDI-DI
00853539002058
Basic UDI-DI
B-00853539002058
EMDN code
W0101050204 Electrolyte controls
GMDN term
Osmolality IVD, control
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Osmolality IVD, control

Similar devices in this category

Other devices filed under ELECTROLYTE CONTROLS.

Other devices from Tearlab Corporation

Properties

  • Single use
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)