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PCR products

EUDAMED

Class A (EU MDR)

Ref PCR-02-8Model PCR-96-HN-C，PCR-96-HS-C，PCR-96-HS-W-P，PCR-96R-HS-C-P，PCR-96R-HS-R-P，PCR-96R-HS-Y-P，PCR-96R-HS-B-P，PCR-96R-HS-G-P，PCR-96R1-HS-C，PCR-96-LS-W，PCR-96-LN-W，PCR-96-LN-C-P，PCR-96-LF-C-P，PCR-96-LH-C，PCR-96-HH-C，etc

by Hangzhou Agen Biotechnology Co Ltd

Identity

Device Name
PCR products EUDAMED
Model / Reference
PCR-96-HN-C，PCR-96-HS-C，PCR-96-HS-W-P，PCR-96R-HS-C-P，PCR-96R-HS-R-P，PCR-96R-HS-Y-P，PCR-96R-HS-B-P，PCR-96R-HS-G-P，PCR-96R1-HS-C，PCR-96-LS-W，PCR-96-LN-W，PCR-96-LN-C-P，PCR-96-LF-C-P，PCR-96-LH-C，PCR-96-HH-C，etc EUDAMED
PCR-02-8 EUDAMED

Identifiers

Primary DI / UDI-DI
06979006040270 EUDAMED
Basic UDI-DI
697900604PCR001GM EUDAMED
EMDN Code
W0503010101 SAMPLES ANALYSES, GLASS TUBES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

PCR products by Hangzhou Agen Biotechnology Co Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hangzhou Agen Biotechnology Co Ltd
EUDAMED SRN
CN-MF-000049623
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 31853319-5fb9-47b4-88af-b752d3ccb2c9 61 fields · synced Jun 18, 2026