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Sources: EU EUDAMED, US FDA
POLYTECH Health & Aesthetics GmbH
Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·MDC MEDICAL DEVICE CERTIFICATION GMBH and MDC MEDICAL DEVICE CERTIFICATION GMBH
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
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
Device
EU MDD
·
Eu Md Class 3
·POLYTECH Health & Aesthetics GmbH·On the market·32 countries
MTIC_017-2019
Certificate
MDD Annex II Section 4·IDS LTD.·MTIC InterCert S.r.l.·1 Basic UDI-DI
0068/QCO-DM/055-2018
Certificate
MDD Annex II Section 4·IDS LTD.·MTIC InterCert S.r.l.·3 Basic UDI-DIs
Juläine
Device
EU MDD
·
Eu Md Class 3
·Nordberg Medical AB·On the market·23 countries
BENOSTAN FORM–B
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
BENOSTAN RTRO-V FILM FORMING EMULSION
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
OKUSCAR ADVANCED GEL
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
HUNMEN GEL
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
FIRST EVER
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
BENOSTAN PSOREEZE
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
TIENE GEL
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
BENOSTAN CLEAR SKIN CREAM
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
BENTOLOG FILM FORMING EMULSION
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
BENOSTAN VITAL-V
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
BENOSTAN VENOCONTRACT GEL
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market
BENOSTAN PHYTOROID CREAM
Device
EU MDD
·
Eu Md Class 1
·BENOSTAN HEALTH PRODUCTS ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ ΠΑΡΑΓΩΓΗΣ ΚΑΙ ΕΜΠΟΡΙΑΣ ΚΑΛΛΥΝΤΙΚΩΝ, ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΚΑΙ ΣΥΝΑΦΩΝ ΠΡΟΙΟΝΤΩΝ / BENOSTAN HEALTH PRODUCTS Α.Ε.·On the market