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Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N

EUDAMED

Class IVD General (EU MDR)

Ref A7712RCFDC-24TRef A7712YF-50TRef A7712RCFDC-48TRef A6382FDC-48T

by Beijing Applied Biological Technologies Co., Ltd.

Identity

Device Name
Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N EUDAMED
Model / Reference
A7712RCFDC-24T EUDAMED
A7712YF-50T EUDAMED
A7712RCFDC-48T EUDAMED
A6382FDC-48T EUDAMED

Identifiers

Primary DI / UDI-DI
06974323013044 EUDAMED
06974323012214 EUDAMED
06974323013051 EUDAMED
06974323013037 EUDAMED
Basic UDI-DI
B-06974323013044 EUDAMED
B-06974323012214 EUDAMED
B-06974323013051 EUDAMED
B-06974323013037 EUDAMED
EMDN Code
W0105041106 CORONAVIRUS - NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Beijing Applied Biological Technologies Co., Ltd.
EUDAMED SRN
CN-MF-000012338
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (4)

  • EUDAMED 1ef90c1d-f1a8-40bd-ba4b-7b7b5d51b91d 61 fields · synced Jul 12, 2026
  • EUDAMED b9e2d1c5-5cfd-4f7b-a063-a3878e35a980 61 fields · synced May 17, 2026
  • EUDAMED 4eb933d7-6cac-43c1-8427-e9df1fadefd2 61 fields · synced May 18, 2026
  • EUDAMED ca4ea832-f014-480d-839b-4ca232b4e2ef 61 fields · synced May 19, 2026