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