Pure Global
210108
II
current

Procedure Kit/Trays, Biopsy, Aspiration, Ultrasound Guidedๆ‰‹ๆœฏๅฅ—ไปถ/ๆ‰˜็›˜,ๆดปๆฃ€,ๆŠฝๅธ,่ถ…ๅฃฐๅผ•ๅฏผ

This profile provides complete Hong Kong MDACS registration information for Procedure Kit/Trays, Biopsy, Aspiration, Ultrasound Guided. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Procedure Kit/Trays, Biopsy, Aspiration, Ultrasound Guided

็”ขๅ“่ณ‡่จŠ๏ผš ๆ‰‹ๆœฏๅฅ—ไปถ/ๆ‰˜็›˜,ๆดปๆฃ€,ๆŠฝๅธ,่ถ…ๅฃฐๅผ•ๅฏผ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
10403
Product Code Detail
10403 Procedure Kit/Trays, Biopsy, Aspiration, Ultrasound Guided
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Manufacturer (่ฃฝ้€ ๅ•†)
CIVCO Medical Instruments Co., Inc. DBA CIVCO and CIVCO Medical Solutions
CIVCO Medical Instruments Co., Inc. DBA CIVCO and CIVCO Medical Solutions
United States
็พŽๅ›ฝ
102 First Street South, Kalona, IA, 52247, United States
102 First Street South, Kalona, IA, 52247, ็พŽ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
April 09, 2021
Expiry Date
April 09, 2026
Product Models
Sterile and Non-sterile Needle Guides and Non-Sterile Brackets (10041822, 10041823, 10136306, 10563771, 10563772, 10658730, 10658731, 10658732, 10658880, 10659481, 10659482, 10787045, 10787095, 10787096, 11014271, 11336181, 11336182, 11336183, 11343996, 11343997, 07848141, 610-1012, 610-1093, 610-1144, 610-1145, 610-1274, 610-1275, 610-139, 610-1429, 610-1430, 610-1431, 610-543, 610-588, 610-590, 610-604, 610-605, 610-666, 610-693, 610-711, 610-842, 610-854, 610-958, 610-959, 610-987, 610-988, 612-051, 612-061, 613-052, 613-057, 613-198, 613-242, 613-245, 613-246, 614-079, 614-089, 614-090, 614-094, 614-095, 614-096, 614-111, 614-114, 614-115, 639-012, 639-013, 644-068, 644-069, 644-092, 644-093, 657-014, 657-024, 657-025, 657-034, 657-035, 657-064, 657-065, 657-066, 657-067, 657-068, 657-069, 657-070, 657-071, 657-072, 657-073, 667-066, 667-089, 667-090, 667-107, 667-108, 667-113, 667-114, 667-115, 667-117, 667-118, 667-121, 667-124, 667-125, 667-133, 667-134, 667-135, 674-015, 674-040, 674-050, 676-110, 676-112, 676-132, 676-133, 676-144, 676-150, 676-154, 676-157, 676-167, 676-206, 677-044, 677-057, 680-092, 680-093, 680-113, 680-114, 680-115, 680-116, 680-117, 680-120, 680-121, 680-130, 680-131, 698-002, 698-010, 698-011, 698-014, 742-042, 742-052, 742-252, 742-270, 742-306, 742-338, 742-378, 742-379, 742-400, E8385MJ, E8385MY, H40462LB, H40462LD, H42742LH, H42742LJ, H46721R, H48681GF, H48691YW, H48691YX, H48691Z, H48701MN, P03372-04, P05649-04)
ๆ— ่Œๅ’Œ้žๆ— ่Œๅฏผ้’ˆๅ™จๅ’Œ้žๆ— ่Œๆ”ฏๆžถ(10041822ใ€10041823ใ€10136306ใ€10563771ใ€10563772ใ€10658730ใ€10658731ใ€10658732ใ€10658880ใ€10659481ใ€10659482ใ€10787045ใ€10787095ใ€10787096ใ€11014271ใ€11336181ใ€11336182ใ€11336183ใ€11343996ใ€11343997ใ€07848141ใ€610-1012ใ€610-1093ใ€610-1144ใ€610-1145ใ€ 610-1274, 610-1275, 610-139, 610-1429, 610-1430, 610-1431, 610-543, 610-588, 610-590, 610-604, 610-605, 610-666, 610-693, 610-711, 610-842, 610-854, 610-958, 610-959, 610-987, 610-988, 612-051, 612-061, 613-052, 613-057, 613-198, 613-242, 613-245, 613-246, 614-079, 614-089, 614-090, 614-094, 614-095, 614-096, 614-111, 614-114, 614-115, 639-012, 639-013, 644-068, 644-069, 644-092, 644-093, 657-014, 657-024, 657-025, 657-034, 657-035, 657-064, 657-065, 657-066, 657-067, 657-068, 657-069, 657-070, 657-071, 657-072, 657-073, 667-066, 667-089, 667-090, 667-107, 667-108, 667-113, 667-114, 667-115, 667-117, 667-118, 667-121, 667-124, 667-125, 667-133, 667-134, 667-135, 674-015, 674-040, 674-050, 676-110, 676-112, 676-132, 676-133, 676-144, 676-150, 676-154, 676-157, 676-167, 676-206, 677-044, 677-057, 680-092, 680-093, 680-113, 680-114, 680-115, 680-116, 680-117, 680-120, 680-121, 680-130, 660-130, 6 80-131, 698-002, 698-010, 698-011, 698-014, 742-042, 742-052, 742-252, 742-270, 742-306, 742-338, 742-378, 742-379, 742-400, E8385MJ, E8385MY, H40462LB, H40462LD, H42742LH, H42742LJ, H46721R, H48681GF, H48691YW, H48691YX, H48691Z, H48701MN, P03372-04, P05649-04)