CE MDR 심사원, 13485 심사원ㅤ
Sterile Water for Inhalation
MATERIAL, IMPRESSION TRAY, RESIN FACEBOW
Absorbable suture
Compressible Limb and Circulation Therapy System
Thermal Massage Bed
Infrared Ear Thermometer
Disposable insulin syringe
Soft contact lens
Sterile esophageal stent
Transcutaneous Electrical Nerve Stimulation Multi needle
Temporary crown
Soft contact lenses
Automatic Microneedle Therapy System
Fixture and Abutment
Computer-aided diagnosis software
HA filler
Solution for contact lens care
Absorbable suture
Regenerative kit-Bone, Fat, Cartilage
Dental implant system
Laser apparatus for medical use
Surgical laser and RF surgical equipment
Plat-panel Digital X-ray detector
RGP & Soft contact lenses
Electrical thermormeter
Disposable insulin syringes
Nd:Yag Surgical Laser치과용 합금
저압지속흡인기, 의약품직접주입기구
매일착용소프트콘택트렌즈
인체조직 또는 기능대치품(인공유방)
구강악안면 고정용판
매일착용하드콘택트렌즈, 연속착용하드콘택트렌즈
비뇨기과용범용튜브카테터
매일착용소프트콘택트렌즈
폴리디옥사논 봉합사
매일착용소프트콘택트렌즈
이식형 결찰사
일회용발조절식전기수술기용전극
흡수성 체내용 지혈용품
두개골 성형재료 (3D 환자맞춤형)
일회용내시경주사침
“일회용발조절식전기수술기용전극,
일회용내시경주사침”
2등급의료영상전송장치소프트웨어Electrodes for ophthalmic electrosurgical devices
Radio frequency (high frequency) Electrosurgical System & Electrode (single use)
Combination stimulator
Mask for medical use (Grade KF94)
Sterile Water for Inhalation
Sterile Single Use PGLA Multifilament Absorbable Loop, PDO Monofilament Absorbable Loop
Clinical Thermometer and Plus oximeter and ECG
Specimen Retrieval Pouch medical devices, PGLA Multifilament Absorbable Loop , PDO Monofilament Absorbable Loop that are surgical apparatus.
Metallic Spinal Bone Fixator, Metallic Bone Trauma Fixator, Porous Nitinol Spinal Cage, Nitinol Mesh, a clip for surgical non-biodegradable
Bone screw and surgical instrument소프트콘택트렌즈 함수공정
“흡수성 체내용 지혈용품, 수액세트,
일회용내시경 캐뉼러”
비흡수성 이식용 클립
Dental Implant System
“GenelixTM Norovirus(G1&G2) Duplex One-step
RT Real-Time PCR Detection kit”