17 results · 9ms · Sources: EU EUDAMED, US FDA

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Spatz FGIA Inc.

Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Albino Dias de Andrade, S.A.

Manufacturer
🇵🇹 Portugal·11 Basic UDI-DIs·83 Devices·SGS Belgium NV

Spatz3 Adjustable Balloon System

Device
EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·On the market·20 countries

ASAHI ZenyteEX PTCA GUIDING CATHETER

Device
EU MDD · Eu Md Class 3 ·ASAHI INTECC CO., LTD.·On the market·30 countries

SBL-2™

Device
EU MDD · Eu Md Class 2b ·Lenstec (Barbados) Inc.·On the market·1 country

ADA Swabs

Device
EU MDD · Eu Md Class 2a ·Albino Dias de Andrade, S.A.·On the market·32 countries

ADA Swabs

Device
EU MDD · Eu Md Class 1 ·Albino Dias de Andrade, S.A.·On the market·32 countries

JADE PTA (JADE 18 OTW)

Device
EU MDD · Eu Md Class 2a ·OrbusNeich Medical (Shenzhen) Co.,Ltd·On the market·1 country

SIORA

Device
EU MDD · Eu Md Class 2b ·SIORA SURGICALS PVT. LTD.·On the market·1 country

OK REAL RESIN BRACKET

Device
EU MDD · Eu Md Class 2a ·Osstem Orthodontics Inc.·No longer on the market

Spatz3 Adjustable Balloon System Insertion Kit

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·1 device

Sterile gauze dressing

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Albino Dias de Andrade, S.A.·1 device

Sterile gauze dressings

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Albino Dias de Andrade, S.A.·1 device

170222 QS/NB

Certificate
MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

ASAHI ZenyteEX PTCA GUIDING CATHETER

Basic UDI-DI
EU MDD · Eu Md Class 3 ·ASAHI INTECC CO., LTD.·1 device

SBL-2

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Lenstec (Barbados) Inc.·1 device

ES19/86854

Certificate
MDD Annex II (excluding section 4)·Albino Dias de Andrade, S.A.·SGS Belgium NV·2 Basic UDI-DIs