Medical Device Division · registration 220047ActiveEpisurf Operations
Hong KongProstheses, Joint, KneeClass IIIEpisurf Operations AB
Official record identity
- MDACS listing number
- 220047
- Model name
- Episealer Condyle Solo (11112, 11115, 11117, 11120), Episealer Trochlea Solo (31120, 31125, 31129), Episealer Femoral Twin (51115, 51117, 51120, 51125)
- Registration date
- July 15, 2026
- Expiry date
- February 07, 2032
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Pacific Medical Systems Limited
- Manufacturer
- Episurf Operations AB
Official description
Prostheses, Joint, Knee
Additional source fields
- AMD nomenclature code
- 16072
- 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.