Medical Device Division · registration 210489ActiveEpisurf Operations AB
Hong KongProsthesis Implantation Instruments, OrthopedicClass IIEpisurf Operations AB
Official record identity
- MDACS listing number
- 210489
- Model name
- Talus Osteotomy Guide (48115), Talus Osteotomy Guide (non-sterile) (48115N), Osteotomy Depth Meter (48215), Osteotomy Depth Meter (non-sterile) (48215N)
- Registration date
- April 22, 2026
- Expiry date
- December 02, 2031
- Source update date
- April 27, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Pacific Medical Systems Limited
- Manufacturer
- Episurf Operations AB
Official description
Prosthesis Implantation Instruments, Orthopedic
Additional source fields
- AMD nomenclature code
- 13180
- Local responsible person phone
- 21084005
- Published manufacturer address
- Karlavagen 60, 114 49 Stockholm, Sweden
- 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.