Medical Device Division · registration 220002ActiveBTL
Hong KongElectrocardiographs, Ambulatory, ContinuousClass IIBTL Industries Limited
Official record identity
- MDACS listing number
- 220002
- Model name
- BTL-08 Holter H100, BTL-08 Holter H300, BTL-08 Holter H600
- Registration date
- March 10, 2025
- Expiry date
- January 20, 2027
- Source update date
- March 13, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- BTL Hong Kong Limited
- Manufacturer
- BTL Industries Limited
Official description
Electrocardiographs, Ambulatory, Continuous
Additional source fields
- AMD nomenclature code
- 18361
- Local responsible person phone
- 28853538
- Published manufacturer address
- 161 Cleveland Way, Stevenage, Hertfordshire SG1 6BU, United Kingdom
- 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.