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Medical Device Division · registration 190333Active

Biosphere Medical

Hong KongSyringes, Plunger, Prefilled, Embolization AgentClass IVBiosphere Medical SA
Official record identity
MDACS listing number
190333
Model name
EmboCube Embolisation Gelatin (EC2525, EC2550, EC25100, EC5025, EC5050, EC50100)
Registration date
June 24, 2024
Expiry date
October 14, 2029
Source update date
January 21, 2026
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Syringes, Plunger, Prefilled, Embolization Agent
Published parties
Registrant / registration holder
Merit Medical Asia Company Limited
Official description

Syringes, Plunger, Prefilled, Embolization Agent

Additional source fields
AMD nomenclature code
20762
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
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.