Centese Inc.

CENTESE, INC.

FDA registration

CENTESE, INC.·2 products·🇺🇸 United States

Thoraguard

FDA UDI

CENTESE, INC.·00860000436427·Thoraguard Control Module

Thoraguard

FDA UDI

CENTESE, INC.·00860000436441·Thoraguard Chest Tube Kit, 28 Fr

Thoraguard

FDA UDI

CENTESE, INC.·00860000436410·Thoraguard Drainage Kit

Thoraguard

FDA UDI

CENTESE, INC.·00860000436403·Thoraguard Chest Tube Kit, 20 Fr

THORAGUARD SYSTEM

FDA Adverse Event

Malfunction ·CENTESE, INC·Product code BTA·August 9, 2025

THOROGUARD

FDA Adverse Event

Injury ·CENTESE, INC.·Product code BTA·June 24, 2025

Thoraguard Chest Tube Kit, 20 Fr

FDA Recall

Terminated ·Centese Inc.·Product code GBX·August 31, 2021

Thoraguard Chest Tube Kit, 20 Fr

FDA Enforcement

Class II ·Terminated·Centese Inc.·October 20, 2021

BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.

Manufacturer

29 Basic UDI-DIs·29 Devices·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, and NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

Prollenium Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·32 Basic UDI-DIs·32 Devices·1 Importer·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, and NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

Nordberg Medical AB

Manufacturer

🇸🇪 Sweden·1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

G. SAMARAS S.A. MEDICAL GAS SYSTEMS

Manufacturer

35 Basic UDI-DIs·35 Devices·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

TH.KAZANTZIDIS SA - MEDIPAC

Manufacturer

2 Basic UDI-DIs·2 Devices·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

SWISS PHARMA DYNAMIC LTD Zweigniederlassung

Manufacturer

🇨🇭 Switzerland·1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

SANDINE ZARTAUX HOLDING LTD

Manufacturer

1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.

Manufacturer

45 Basic UDI-DIs·45 Devices·HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

CENTER HEALTH INC.

FDA registration

CENTER HEALTH INC.·1 product·🇺🇸 United States

Lira Center Inc

FDA registration

Lira Center Inc·1 product·🇺🇸 United States

GLASSESUSA FULFILLMENT CENTER, INC.

FDA registration

GLASSESUSA FULFILLMENT CENTER, INC.·4 products·🇺🇸 United States