Medical Device Division · registration 150055ExpiredMedtronic Xomed
Hong KongProstheses, Middle Ear OssicleClass IIIMedtronic Xomed, Inc.
Official record identity
- MDACS listing number
- 150055
- Model name
- Ossicular Reconstruction Implants (0300, 0305, 0306, 0308, 0320, 0321, 0322, 0340, 0341, 0342, 0343, 0352, 0353, 0361, 0362, 0363, 0364, 0380, 0385, 0427, 0428, 0429, 0435, 0436, 0437, 0440, 0450, 0451, 0452, 0500, 0501, 0504, 0505, 0506, 0507, 0508, 0510, 0512, 0513, 0515, 0516, 0518, 0520, 0523, 0524, 0525, 0526, 0527, 0528, 0529, 0530, 0531, 0532, 0540, 0541, 0543, 0550, 0551, 0555, 0557, 0559, 0560, 0562, 0563, 0564, 0565, 0567, 0568, 0570, 0574, 0575, 0577, 0579, 0580, 0581, 0585, 0586, 0590, 0594, 0595, 0596, 0597, 0598, 05011, 05031, 05251, 05321, 05421, 1112045, 1112050, 1112065, 1112070, 1112075, 1112080, 1112085, 1112090, 1112091, 1112092, 1112095, 1112096, 1112097, 1112120, 1112162, 1112163, 1112165, 1112167, 1112170, 1112172, 1112175, 1112180, 1112181, 1112182, 1112183, 1112184, 1112185, 1112190, 1112192, 1112194, 1112195, 1112197, 1112296, 1112297, 1112298, 1112303, 1112305, 1112362, 1112363, 1112372, 1117035, 1117040, 1117045, 1117105, 1117110, 1117115, 1117120, 1117125, 1125020, 1125025, 1125030, 1128110, 1128115, 1128120, 1128125, 1128130, 1128135, 1128140, 1128145, 1128150, 1128155, 1128160, 1128165, 1128180, 1128300, 1128305, 1128400, 1128405, 1128450, 1129015, 1129020, 1129030, 1129040, 1129045, 1129050, 1129055, 1129065, 1129070, 1131000, 1131050, 1133001, 1133002, 1133003, 1133004, 1133005, 1133006, 1133007, 1133008, 1133009, 1133010, 1133031, 1133032, 1133038, 1133042, 1133061, 1133062, 1133063, 1133064, 1133065, 1133066, 1133120, 1133125, 1133135, 1133180, 1133185, 1133190, 1133191, 1133195, 1133210, 1133250, 1133255, 1133260, 1133265, 1133270, 1133280, 1133285, 1133290, 1133295, 1133300, 1133370, 1133372, 1133375, 1133600, 1133650, 1150000, 1150001, 1150050, 1156210, 1156211, 1156212, 1156213, 1156214, 1156221, 1156222, 1156223, 1156224, 1156234, 1156235, 1156236, 1156241, 1156255, 1156256, 1156257, 1156258, 1156278, 1156279, 1156280, 1156281, 1156282, 1156283, 1156295, 1156296, 1156297, 1156298, 1156302, 1156303, 1156304, 1156305, 1156307, 1156308, 1156310, 1156314, 1156316, 1156324, 1156325, 1156326, 1156330, 1156331, 1156332, 1156333, 1156334, 1156340, 1156341, 1156342, 1156343, 1156344, 1156346, 1156347, 1156348, 1156358, 1156359, 1156361, 1156362, 1156363, 1156372, 1156376, 1156377, 1156378, 1156379, 1156452, 1156453, 1156454, 1156468, 1156469, 1156470, 1156479, 1156480, 1156481, 1156601, 1156602, 1156603, 1156604, 1156611, 1156612, 1156613, 1156621, 1156622, 1156623, 1160000, 1160050, 1425015, 1425020, 1428005, 1428010, 9100420, 9100522, 9131001, 9131002, 9156241, EN0002)
- Registration date
- January 10, 2020
- Expiry date
- April 23, 2025
- Source update date
- July 11, 2023
- Status
- Expired
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- Medtronic Xomed, Inc.
Official description
Prostheses, Middle Ear Ossicle
Additional source fields
- AMD nomenclature code
- 16147
- Traditional Chinese local responsible person
- 美敦力香港醫療有限公司
- Local responsible person phone
- 29191300
- Published manufacturer address
- 6743 Southpoint Drive North, Jacksonville FL 32216, USA
- Published remarks
- Expired.
- Revision number
- b
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.