Medical Device Division · registration 230017ActiveDr. Langer Medical
Hong KongMonitors, Physiologic, Neurology, IntraoperativeClass IIDr. Langer Medical GmbH
Official record identity
- MDACS listing number
- 230017
- Model name
- Neuromonitor AVALANCHE XT (20-0023), AVALANCHE XT Headbox (21-0022, 21-0023, 21-0025, 21-0026, 21-0027, 21-0028), AVALANCHE XT Software (30-1100, 30-1101, 30-1102, 30-1103, 30-1104, 30-1105), TWISTER MM Modul (20-0007), AEP Modul (20-0003), AVALANCHE XT Anschlusskabel (41-0018, 41-0019, 41-0020, 41-0036), AVALANCHE XT Mute-Sensor (21-0005, 21-0020), EMG signal acquisition cable (41-0010, 41-0068, 41-0069, 41-0070), Adapter (41-0048, 41-0080), Connection cable stimulation probes (41-0002, 41-0027), Disposable Stimulation Probe (40-1003, 40-1004, 40-1006, 40-1007, 40-1008), Saxophone electrode (42-0068), Adhesive tube electrode (42-9600, 42-9601), Stimulation Cable (41-0073, 41-0074, 41-0075, 41-0105)
- Registration date
- September 25, 2025
- Expiry date
- January 19, 2028
- Source update date
- February 05, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Enritech Medical Company Limited
- Manufacturer
- Dr. Langer Medical GmbH
Official description
Monitors, Physiologic, Neurology, Intraoperative
Additional source fields
- AMD nomenclature code
- 34440
- Traditional Chinese local responsible person
- 艾美迪醫療器材有限公司
- Local responsible person phone
- 96231080
- Published manufacturer address
- Am Bruckwald 26, 79183 Waldkirch, Germany
- 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.