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Bullfrog Micro-Infusion Device MDL12-3060-145-HT

by Mercator MedSystems, Inc.

Ref BF102MModel MDL12-3060-145-HT

Bullfrog Micro-Infusion Device MDL12-3060-145-HT (BF102M) 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-+M973BF102M15) and listed in FDA GUDID since 23 Feb 2018 (UDI-DI +M973BF102M15), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+M973BF102M15 Basic UDI-DI +M973BF102M15UDI-DIDate17 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+M973BF102M15 UDI-DI Date23 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+M973BF102M15 registered 17 Oct 2026 Active
  • FDA GUDID UDI-DI +M973BF102M15 listed 23 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +M973BF102M15
  2. Registered EUDAMED B-+M973BF102M15

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  • Withdrawn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
Bullfrog EUDAMED
Bullfrog Micro-Infusion Device GUDID
Generic name
Peripheral vascular intervention infusion catheter
Model / Ref / Catalog
MDL12-3060-145-HT, BF102M
Primary DI / UDI-DI
+M973BF102M15 EUDAMED
M973BF102M1 GUDID
Basic UDI-DI
B-+M973BF102M15
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
+M973BF102M15
GUDID
M973BF102M1
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +M973BF102M15; FDA GUDID lists M973BF102M1), 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

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)