Medical Device Division · registration 130342ActiveRespironics
Hong KongMasks, Air-OxygenClass IIRespironics, Inc
Official record identity
- MDACS listing number
- 130342
- Model name
- AF531 Oro-Nasal Single-Use EE Leak 1 (1061718, 1061719, 1061720, 1061727, 1061728, 1061729, 1072621, 1072622, 1072623, 1072627,1072628, 1072629), AF531 Oro-Nasal Single-Use EE Leak 2 (1061724, 1061725, 1061726, 1100390, 1100391, 1100392, 1100393, 1100394, 1100395), AF531 Oro-Nasal Single-Use SE (1061721, 1061722, 1061723, 1061730, 1061731, 1061732, 1134804, 1072624, 1072625, 1072626, 1072630, 1072631, 1072632, 1134715), AF531 Oro-Nasal, Single-Use, Circuit with Filter, EE Leak 1 (1072639, 1072640, 1072641), Nebulizing Elbow (1072649, 1072650, 1076755, 1076754), Bronchoscopy Elbow (1072651, 1072652), AF531 Oro-Nasal Single-Use EE Leak 1 with Nebulizing Elbow (1072633, 1072634, 1072635, 1072636, 1072637, 1072638, 1072642, 1072643, 1072644), AF531 Oro-Nasal Single-Use SE with Nebulizing Elbow (1100396, 1100397, 1100438)
- Registration date
- October 11, 2023
- Expiry date
- October 11, 2028
- Source update date
- March 06, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Philips Electronics Hong Kong Limited
- Manufacturer
- Respironics, Inc
Official description
Masks, Air-Oxygen
Additional source fields
- AMD nomenclature code
- 12448
- Traditional Chinese local responsible person
- 飛利浦電子香港有限公司
- Local responsible person phone
- 28215888
- Published manufacturer address
- 1001 Murry Ridge Lane, Murrysville, PA 15668-8550, USA
- Revision number
- c
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.