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PCR products

EUDAMED

Class A (EU MDR)

Ref PCR-0108Model 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，etcRef PCR-401-C-PRef PCR-96-LN-WRef PCR-96R-HS-R-PRef PCR-0208H-WRef PCR-96R-HS-G-PRef PCR-402-WRef PCR-0208Ref PCR-96-HS-W-PRef PCR-96R-HS-C-PRef PCR-0108H-WRef PCR-0108-WRef PCR-96-LS-WRef PCR-96-HH-CRef PCR-96-HS-CRef PCR-96R-HS-B-P

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-0108 EUDAMED
PCR-401-C-P EUDAMED
PCR-96-LN-W EUDAMED
PCR-96R-HS-R-P EUDAMED
PCR-0208H-W EUDAMED
PCR-96R-HS-G-P EUDAMED
PCR-402-W EUDAMED
PCR-0208 EUDAMED
PCR-96-HS-W-P EUDAMED
PCR-96R-HS-C-P EUDAMED
PCR-0108H-W EUDAMED
PCR-0108-W EUDAMED
PCR-96-LS-W EUDAMED
PCR-96-HH-C EUDAMED
PCR-96-HS-C EUDAMED
PCR-96R-HS-B-P EUDAMED

Identifiers

Primary DI / UDI-DI
06979006040256 EUDAMED
06979006040201 EUDAMED
06979006040119 EUDAMED
06979006040058 EUDAMED
06979006040294 EUDAMED
06979006040089 EUDAMED
06979006040188 EUDAMED
06979006040232 EUDAMED
06979006040034 EUDAMED
06979006040041 EUDAMED
06979006040317 EUDAMED
06979006040263 EUDAMED
06979006040102 EUDAMED
06979006040157 EUDAMED
06979006040027 EUDAMED
06979006040072 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 (16)

  • EUDAMED 2fe24ff7-3244-47c3-a234-92434832d0b7 61 fields · synced Oct 6, 2026
  • EUDAMED 4cdae0a8-19cd-473c-9617-a98c14e782e2 61 fields · synced May 16, 2026
  • EUDAMED cfcac596-5e37-4925-a447-19c19914c81d 61 fields · synced May 17, 2026
  • EUDAMED bb62dcea-9d0f-4d70-96d1-63f4ac298119 61 fields · synced May 17, 2026
  • EUDAMED 73d71839-8562-4381-a3f1-828bbd7de616 61 fields · synced May 17, 2026
  • EUDAMED ab5ff09c-7dec-441b-9aa5-9bc3114fba5a 61 fields · synced May 17, 2026
  • EUDAMED 5033ff43-e32b-48ff-9ab9-f87452820d7b 61 fields · synced May 18, 2026
  • EUDAMED b46a8aaa-43e0-426e-a751-d167cbe6b0f3 61 fields · synced May 18, 2026
  • EUDAMED 9c254687-f5bc-419d-aff2-3384468e6b5d 61 fields · synced May 18, 2026
  • EUDAMED 5db8c3be-9ce4-4a20-8d88-644c506ea271 61 fields · synced May 18, 2026
  • EUDAMED 000fbe11-f69a-4a1e-a9f6-4e48db24d0ba 61 fields · synced May 18, 2026
  • EUDAMED d652cfec-d88a-43ce-9d7c-78798a1ba5b8 61 fields · synced May 18, 2026
  • EUDAMED acf5b92f-b82c-4e49-b7a1-c15488afe75b 61 fields · synced May 18, 2026
  • EUDAMED 9b90748f-2214-47b2-8e35-5a5a10e4bd26 61 fields · synced May 18, 2026
  • EUDAMED 644cdf01-e352-45c5-93bd-16303116e0c6 61 fields · synced May 18, 2026
  • EUDAMED 9a428241-407b-4497-a45b-ec0915fbac45 61 fields · synced May 19, 2026