Medical Device Division · registration 140361ActiveBiosphere Medical
Hong KongGuide WiresClass IIBiosphere Medical SA
Official record identity
- MDACS listing number
- 140361
- Model name
- Tenor steerable guidewire (TNR2411, TNR2412, TNR2811, TNR2812)
- Registration date
- June 24, 2024
- Expiry date
- October 16, 2029
- Source update date
- January 21, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Merit Medical Asia Company Limited
- Manufacturer
- Biosphere Medical SA
Official description
Guide Wires
Additional source fields
- AMD nomenclature code
- 11925
- Local responsible person phone
- 22076851
- Published manufacturer address
- Parc des Nations, Paris Nord 2, 383, rue de la Belle Etoile, Roissy-en-France, 95700, France
- 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.