Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - anaesthesiology - the intended application of the neopuff infant resuscitatoris to deliver assisted respiratory breaths to infants, weighing up to 10 kg, when required, until adequate spontaneous breathing occurs or until the patient can be transferred to alternative respiratory support.

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - general hospital - this is intended to be used by individuals who have been diagnosed by a physician as requiring cpap or bi-level ventilator treatment. the f&p pilairo q nasal pillows mask is intended for single-patient adult use in the home and multiple-patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - general hospital - the f&p simplus full face mask is intended to be used by individuals who have been diagnosed by a physician as requiring cpap or bi-level ventilator treatment. the f&p simplus full face mask is intended for single patient adult use in the home and multiple patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - general & plastic surgery - the device is for use on adult patients for the treatment of obstructive sleep apnea (osa). the device is for use in the home or sleep laboratory.

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - general hospital - clinell sporicidal wipes are disinfectant and cleaning wipes activated by water. for the disinfection of non-invasive medical devices such as commodes. not for end point sterilisation or high level disinfection.

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - orthopaedics - the castleloc-s posterior cervical fixation system is indicated for the following: • ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) • spondylolisthesis • spinal stenosis • fracture/dislocation • failed previous fusion • tumors the implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine. hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (c1 –t3) spine. the polyaxial screws are limited to placement in t1-t3 in treating thoracic conditions only. the polyaxial screws are not intended to be placed in or treat conditions involving the cervical and upper thoracic spine.

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - orthopaedics - l&k biomed openloc-l spinal fixation system is intended for use as posterior pedicle screw fixation systems (t1-s2/ilium), or as an anterolateral fixation system (t8-l5). all components in the system are limited to skeletally mature patients and are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease, spondylolisthesis, trauma (fracture or dislocation), deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, stenosis, and pseudoarthrosis. it is indicated for the treatment of severe spondylolisthesis (grade 3 and 4) of the l5-s1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (l3 to sacrum) with removal of the implants after the attainment of a solid fusion .in addition, the system is intended to provide immobilization and stabilization of spinal segments

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - general hospital - the sole purpose of the trophon epr is to high level disinfect validated ultrasound probes.

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - general hospital - the trophon2 is intended for the high level disinfection (hld) of non-lumened, reusable, transiently invasive and non-invasive medical instruments/devices e.g. devices that are intended for use for imaging, diagnostic, ablation, coagulation and their accessories. the trophon2 is designed to provide high-level disinfection (hld) of validated ultrasound probes. high-level disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe. the trophon2 system consists of a multiple use instrument combined with a single use disinfectant “trophon nanonebulant”, delivered from a multi-dose cartridge. the trophon2 is suitable for use in general hospital and health care facilities by trained personnel. the trophon2 is not intended to reprocess single-use devices or pre-clean medical instruments.

Singapore - engelsk - HSA (Health Sciences Authority)

emergo singapore consulting private limited - general & plastic surgery - silhouette soft is a resorbable sterile implantable single-use device intended to be used in adult patients for facial and neck reconstruction in the treatment of facial morphological asymmetry and ptosis, including but not limited to: - the effects of facial ptosis or paralysis (e.g. bell’s palsy, benign or malignant tumours, iatrogenic injury, varicella-zoster virus associated facial palsy, trauma, and congenital palsy). - morphological asymmetry (e.g. congenital anomalies, trauma to the face or the temporomandibular joint).