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LEAPFROG Micro-Infusion Device MDL18-0616-120-HT

by Mercator MedSystems, Inc.

Ref BF103PModel MDL18-0616-120-HT

LEAPFROG Micro-Infusion Device MDL18-0616-120-HT (BF103P) is a device classified as Class IIa in the EU and Class II in the US made by Mercator MedSystems, Inc., registered in EUDAMED on 17 Oct 2026 (Basic UDI-DI B-+M973BF103P19), cleared under FDA 510(k) K210339 on 2 Aug 2021 and listed in FDA GUDID since 17 Apr 2023 (UDI-DI +M973BF103P19), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210339

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+M973BF103P19 Basic UDI-DI +M973BF103P19UDI-DIDate17 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+M973BF103P19 UDI-DI Date17 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210339 Date2 Aug 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+M973BF103P19 registered 17 Oct 2026 Active
  • FDA 510(k) K210339 decided 2 Aug 2021 Active
  • FDA GUDID UDI-DI +M973BF103P19 listed 17 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K210339
  2. Listed FDA GUDID +M973BF103P19
  3. Registered EUDAMED B-+M973BF103P19

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Leapfrog EUDAMED
LEAPFROG Micro-Infusion Device GUDID
Generic name
Peripheral vascular intervention infusion catheter
Model / Ref / Catalog
MDL18-0616-120-HT, BF103P
Primary DI / UDI-DI
+M973BF103P19 EUDAMED
M973BF103P1 GUDID
Basic UDI-DI
B-+M973BF103P19
510(k) Number
FDA product code
KRA
EMDN code
C0104020205 Pharmaceutical infusion and administration intravascular catheters and microcatheters
GMDN term
Peripheral vascular intervention infusion catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1210
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+M973BF103P19
GUDID
M973BF103P1
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +M973BF103P19; FDA GUDID lists M973BF103P1), so their flags are not compared. 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.

Related devices

Category: Peripheral vascular intervention infusion catheterCoronary artery infusion catheter

Cleared under the same submission (K210339)

Similar devices in this category

Other devices filed under PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS.

Other devices from Mercator MedSystems, Inc.

See all devices from Mercator MedSystems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)