4,683 results · 47ms · Sources: EU EUDAMED, US FDA

COPRA TEMP PMMA-DISK

FDA 510(k)
FDA Class 2 ·Dental

CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Safety belt HAR1

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Suomen Laitostekstiilit Ky·1 device

Rescue sheet

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Suomen Laitostekstiilit Ky·1 device

Seating

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Ki Mobility LLC·11 devices

Manual Wheelchair

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Ki Mobility LLC·18 devices

Kai Europe GmbH

Authorized representative
🇩🇪 Germany·1 Manufacturer·6 Devices

HZ 2066395-1

Certificate
MDR QMS·Kai Industries Co., Ltd.·TÜV Rheinland LGA Products GmbH

TRİMPEKS İTHALAT İHRACAT TURİZM VE TİCARET A.Ş.

Importer
🇹🇷 Türkiye·1 Manufacturer

3M Deutschland GmbH (Medical)

Authorized representative
🇩🇪 Germany·3 Manufacturers

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

TR-Manual Multifunktion table

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Ortopedinen Osteopaatti T.Rantala ky·1 device

KCI Manufacturing Unlimited Company

Authorized representative
🇮🇪 Ireland·3 Manufacturers

Skypro, SP02 Mask (3)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Skypro, SP01 Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Ki

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

Immunocytochemistry Assay, P16/Ki-67

FDA classification
FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

FDA classification
FDA Class 1 ·Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

Sportcare Ky

Importer
🇫🇮 Finland