Medical Device Division · registration 240185ActiveDevicor Medical Products
Hong KongBiopsy Site Markers, BreastClass IVDevicor Medical Products, Inc.
Official record identity
- MDACS listing number
- 240185
- Model name
- HydroMARK Breast Biopsy Site Markers (4010-01-08-T1, 4010-01-08-T3, 4010-01-08-T4, 4010-01-08-S1, 4010-04-09-T1, 4010-04-09-T3, 4010-04-09-T4, 4010-04-09-S3, 4010-01-11-T1, 4010-01-11-T3, 4010-01-11-T4, 4010-02-15-S1, 4010-02-15-S3, 4010-02-15-T1, 4010-02-15-T3, 4010-02-15-T4, 4010-03-15-T1-SHORT, 4010-03-15-T3-SHORT, 4010-02-18-T3)
- Registration date
- December 18, 2025
- Expiry date
- May 20, 2029
- Source update date
- December 19, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Prism Technologies Limited
- Manufacturer
- Devicor Medical Products, Inc.
Official description
Biopsy Site Markers, Breast
Additional source fields
- AMD nomenclature code
- 39659
- Traditional Chinese local responsible person
- 稜科有限公司
- Local responsible person phone
- 27863233
- Published manufacturer address
- Fifth Floor, 300 E-Business Way, Cincinnati OH 45241, USA
- Revision number
- a
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.