Novel

FDA UDI

ALPHATEC SPINE, INC.·00190376275420·NOVEL CERVICAL SPINAL SPACER IMP/INST

BIS Monitor interface cable

Device

EU MDR · Eu Md Class 1 ·Fukuda Denshi Co., Ltd.·On the market·32 countries

BIS Monitor interface cable

Device

EU MDR · Eu Md Class 1 ·Fukuda Denshi Co., Ltd.·On the market·32 countries

ManufixLoc Handgelenkumfang bis 17cm

Device

EU MDR · Eu Md Class 1 ·Achim Ruthner GmbH·On the market

ORYX DIS TICARET LIMITED SIRKETI

Manufacturer

🇹🇷 Türkiye·7 Basic UDI-DIs·7 Devices·MTIC InterCert S.r.l.

Mayamed Tekstil Dış Ticaret LTD.ŞTİ

Manufacturer

🇹🇷 Türkiye

ERC BİYOTEKNOLOJİ SAN.VE DIŞ TİC.AŞ.

Manufacturer

🇹🇷 Türkiye·1 Basic UDI-DI·1 Device·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi

Active Optical Systems Ltd

Manufacturer

🇮🇱 Israel·6 Basic UDI-DIs·6 Devices·MDC MEDICAL DEVICE CERTIFICATION GMBH and MDC MEDICAL DEVICE CERTIFICATION GMBH

Top Engineering Sarl

Manufacturer

🇨🇭 Switzerland·4 Basic UDI-DIs·4 Devices

BIS ENGINE

FDA 510(k)

FDA Class 2 ·Neurology

SKAFFOLD CIS

FDA 510(k)

FDA Unclassified ·Unknown

BIS ENGINE

FDA 510(k)

FDA Class 2 ·Neurology

Hospital Information System qMS

Device

EU MDD · Eu Md Class 1 ·CJSC SP.ARM·On the market

BVI1689 (EP1) - Canaliculus Intubation Set (CIS) 15.5 Cm Long

FDA registration

ISOMEDIX OPERATIONS INC·1 product·🇺🇸 United States

ARTEOTOMY Oral Surgery System and Accessories (Model No. BIS)

FDA registration

BONART CO. LTD.·1 product·🇹🇼 Taiwan

TEKMİL DİŞ HEKİMLİĞİ VE TIBBİ CİHAZLAR ÜRETİM İÇ VE DIŞ TİC SAN A.Ş

Manufacturer

🇹🇷 Türkiye

Re-Trace Ureteral Access Sheath

FDA registration

Sterigenics SAS·1 product·🇫🇷 France

X-Flow Prostactectomy Catheter, Straight

FDA registration

Sterigenics SAS·1 product·🇫🇷 France

Biosoft duo Double Loop Ureteral stents

FDA registration

Sterigenics SAS·1 product·🇫🇷 France

Integral Lumbar Drainage Set

FDA registration

Sterigenics SAS·1 product·🇫🇷 France