Medical Device Division · registration 190189ActiveDatex-Ohmeda
Hong KongPhototherapy Units, Visible Light, HyperbilirubinemiaClass IIDatex-Ohmeda, Inc.
Official record identity
- MDACS listing number
- 190189
- Model name
- Lullaby LED Phototherapy System
- Registration date
- April 22, 2026
- Expiry date
- July 15, 2029
- Source update date
- April 23, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
- Published category
- Phototherapy Units, Visible Light, Hyperbilirubinemia
Official value: II
Published parties
- Registrant / registration holder
- GE Medical Systems Hong Kong Limited
- Manufacturer
- Datex-Ohmeda, Inc.
Official description
Phototherapy Units, Visible Light, Hyperbilirubinemia
Additional source fields
- AMD nomenclature code
- 17515
- Local responsible person phone
- 21006300
- Published manufacturer address
- 3114 N Grandview Blvd, Waukesha, WI 53188, USA
- 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.