241128
IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme
体外诊断检测试剂/试剂盒、临床化学、酶、乳酸脱氢酶、同工酶
Roche Diagnostics GmbH·B·Hong Kong MDACS·Registered October 16, 2024
Device overview
- Risk class
- B
- Product code
- 18889
- State
- current
- Status
- N/A
- Product code detail
- 18889 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme
Manufacturer (製造商)
- Name
- Roche Diagnostics GmbHRoche Diagnostics Gmbh
- Address
- Sandhofer Strasse 116, 68305 Mannheim, GERMANYSandhofer Strasse 116, 68305 曼海姆, 德国
Authorised representative (AR)
- Phone
- 24813387
Regulatory timeline
- Registration date
- October 16, 2024
- Expiry date
- October 15, 2029
Product models
HBDH2 (05480175190, 05480175214, 06750036190, 08106053190)
HBDH2(05480175190、05480175214、06750036190、08106053190)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme
產品資訊: 体外诊断检测试剂/试剂盒、临床化学、酶、乳酸脱氢酶、同工酶