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Medical Device Division · registration 240265Active

PHADIA

Hong KongIVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin AIVD Class BPHADIA AB
Official record identity
MDACS listing number
240265
Model name
EliA GliadinDP IgA (14-5538-01)
Registration date
November 03, 2025
Expiry date
July 22, 2029
Status
Active
Official value: Valid
Classification
Risk class
IVD Class B
Official value: B
Published category
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A
Published parties
Registrant / registration holder
Thermo Fisher Scientific (Hong Kong) Limited
Manufacturer
PHADIA AB
Official description

IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A

Additional source fields
AMD nomenclature code
17369
Traditional Chinese local responsible person
賽默飛世爾科技(香港)有限公司
Local responsible person phone
31077600
Published manufacturer address
Rapsgatan 7P PO. Box 6460, 751 37 UPPSALA SWEDEN
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.