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Dexcom CLARITY 350-0011

by Sweetspot Diabetes Care, Inc.

Ref 350-0013, 350-0021, 350-0011Model Dexcom Clarity

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038627CLARITY48 Basic UDI-DI Date20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00386270000705 UDI-DI Date26 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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

Trade Name
Dexcom CLARITY
Generic Name
Noninvasive interstitial fluid glucose monitoring device
Percutaneous interstitial fluid glucose monitoring system, electrochemical
Model / Ref / Catalog
350-0011, Dexcom Clarity, 350-0013, 350-0021
Description
Data Manager Software
Primary DI / UDI-DI
00386270000705 EUDAMED
00386270000699 EUDAMED
00386270000491 EUDAMED
B059CLARITY35000011 GUDID
00038270000451 GUDID
Basic UDI-DI
038627CLARITY48
De Novo Number
FDA Product Code
PHV
EMDN Code
Z1204011501 Non invasive blood sugar monitoring systems
GMDN Term
Noninvasive interstitial fluid glucose monitoring device
Percutaneous interstitial fluid glucose monitoring system, electrochemical
Device Class
Class I
Regulation Number
862.2120
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00386270000705
00386270000699
00386270000491
GUDID
B059CLARITY35000011
00038270000451

Other devices from Sweetspot Diabetes Care, Inc.

Properties

  • Prescription Use NoGUDIDYesGUDID
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number YesGUDIDNoGUDID
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No