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01 1AB ANALITICA Srl

02 1DXS DEVICES

03 1Ferrer Internacional

04 3ITC FARMA Srl

05 2Infai Ch Gmbh

06 2Infai Gmbh

07 1Isomed Pharma Sl

08 2Mayoly Spindler

09 1Meridian Bioscience

10 1Metabolic Solutions

11 2Otsuka America Pharmaceutical, Inc.

12 1RICHEN CORTEX EUROPE Srl

13 2Sofar Spa

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PharmaCompass

01

OTS 2025
Not Confirmed
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OTS 2025
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13-C Urea

Brand Name : Ubtest

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 2006-03-28

Application Number : 67650

Regulatory Info : Authorized

Registration Country : Spain

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02

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

13-C Urea

Brand Name : Helikit

Dosage Form : Powder For Oral Solution

Dosage Strength : 75MG

Packaging :

Approval Date : 2019-05-21

Application Number : 83391

Regulatory Info : Cancelled

Registration Country : Spain

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03

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

13-C Urea

Brand Name : Espikur

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date : 2019-12-10

Application Number : 84708

Regulatory Info : Authorized

Registration Country : Spain

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04

OTS 2025
Not Confirmed
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OTS 2025
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CITRIC ACID; UREA C-13

Brand Name : IDKIT:HP

Dosage Form : FOR SOLUTION, TABLET, FOR SOLUTION;ORAL

Dosage Strength : 4GM;75MG

Packaging :

Approval Date : 2002-12-17

Application Number : 21314

Regulatory Info : RX

Registration Country : USA

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05

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

UREA C-13

Brand Name : HELICOSOL

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 125MG/VIAL

Packaging :

Approval Date : 1999-12-17

Application Number : 21092

Regulatory Info : DISCN

Registration Country : USA

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06

OTS 2025
Not Confirmed
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OTS 2025
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UREA C-13

Brand Name : MERETEK UBT KIT (W/ PRANACTIN)

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 125MG/VIAL

Packaging :

Approval Date : 1996-09-17

Application Number : 20586

Regulatory Info : DISCN

Registration Country : USA

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07

OTS 2025
Not Confirmed
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OTS 2025
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UREA C-13

Brand Name : BREATHTEK UBT FOR H-PYLORI

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : EQ 75MG/POUCH

Packaging :

Approval Date : 2001-05-10

Application Number : 20586

Regulatory Info : DISCN

Registration Country : USA

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08

OTS 2025
Not Confirmed
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OTS 2025
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Urea C13

Brand Name : Expirobacter

Dosage Form : C-13 Urea 100Mg 1 Combined Oral Use

Dosage Strength : 1 CPR 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

Urea C13

Brand Name : Expirobacter

Dosage Form : C-13 Urea 100Mg 1 Combined Oral Use

Dosage Strength : 1 cpr solub 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

DXS DEVICES

Country
OTS 2025
Not Confirmed
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DXS DEVICES

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OTS 2025
Not Confirmed

UREA C-13

Brand Name : PYLORI-CHEK BREATH TEST

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 100MG/VIAL

Packaging :

Approval Date : 1999-02-04

Application Number : 20900

Regulatory Info : DISCN

Registration Country : USA

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11

ITC FARMA Srl

Country
OTS 2025
Not Confirmed
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ITC FARMA Srl

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OTS 2025
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 37.5 Mg 2 Units' Oral Use

Dosage Strength : 2 CPR 37.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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12

ITC FARMA Srl

Country
OTS 2025
Not Confirmed
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ITC FARMA Srl

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OTS 2025
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 75Mg 1 Combined Oral Use

Dosage Strength : 1 CPR 75 mg + Kit

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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13

RICHEN CORTEX EUROPE Srl

Country
OTS 2025
Not Confirmed
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RICHEN CORTEX EUROPE Srl

Country
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OTS 2025
Not Confirmed

Urea C13

Brand Name : Citredici Ubt Kit

Dosage Form : C-13 Urea 75Mg 1 Combined Oral Use

Dosage Strength : 1 bottle os 75 mg + 1 envelope

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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14

AB ANALITICA Srl

Country
OTS 2025
Not Confirmed
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AB ANALITICA Srl

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OTS 2025
Not Confirmed

Urea C13

Brand Name : Breathquality-Ubt

Dosage Form : C-13 Urea 75Mg 10Ml Oral Use

Dosage Strength : os soluz 75 mg 10 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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15

ITC FARMA Srl

Country
OTS 2025
Not Confirmed
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ITC FARMA Srl

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OTS 2025
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 75Mg 18 Units Of Oral Use

Dosage Strength : 18 CPR 75 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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16

Infai Ch Gmbh

Country
OTS 2025
Not Confirmed
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Infai Ch Gmbh

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OTS 2025
Not Confirmed

Carbon(13-C) Urea

Brand Name : Helicobacter Test INFAI

Dosage Form : Diagnostic

Dosage Strength : 75mg

Packaging :

Approval Date : 16/09/1998

Application Number : 54685

Regulatory Info : Allowed

Registration Country : Switzerland

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17

Infai Ch Gmbh

Country
OTS 2025
Not Confirmed
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Infai Ch Gmbh

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OTS 2025
Not Confirmed

Carbon(13-C) Urea

Brand Name : Helicobacter Test INFAI

Dosage Form : Diagnostic

Dosage Strength : 45mg

Packaging :

Approval Date : 16/09/1998

Application Number : 54685

Regulatory Info : Allowed

Registration Country : Switzerland

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18

Isomed Pharma Sl

Country
OTS 2025
Not Confirmed
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Isomed Pharma Sl

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OTS 2025
Not Confirmed

13-C Urea

Brand Name : Tau-Kit Soluble Tablets

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date : 1998-02-01

Application Number : 61805

Regulatory Info : Authorized

Registration Country : Spain

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19

Infai Gmbh

Country
OTS 2025
Not Confirmed
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Infai Gmbh

Country
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OTS 2025
Not Confirmed

13-C Urea

Brand Name : Helicobacter Test Infai

Dosage Form : Powder For Oral Solution

Dosage Strength : 75MG

Packaging :

Approval Date : 1998-02-01

Application Number : 97045001

Regulatory Info : Authorized

Registration Country : Spain

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20

Infai Gmbh

Country
OTS 2025
Not Confirmed
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Infai Gmbh

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OTS 2025
Not Confirmed

13-C Urea

Brand Name : Helicobacter Test Infai For Children Between The Ages

Dosage Form : Solution

Dosage Strength : 45MG

Packaging :

Approval Date : 2019-11-15

Application Number : 197045003

Regulatory Info : Authorized

Registration Country : Spain

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