← Back to catalogue

Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)

EUDAMED

Class IVD General (EU MDR)

Ref 212901

by Yaneng BIOscience (Shenzhen) Co., Ltd.

Identity

Trade Name
Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis) EUDAMED
Device Name
Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis) EUDAMED
Model / Reference
212901 EUDAMED

Identifiers

Primary DI / UDI-DI
06955931302881 EUDAMED
06955931302874 EUDAMED
06955931302904 EUDAMED
06955931302898 EUDAMED
Basic UDI-DI
B-06955931302881 EUDAMED
B-06955931302874 EUDAMED
B-06955931302904 EUDAMED
B-06955931302898 EUDAMED
EMDN Code
W0105041005 OTHER HPV - NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis) by Yaneng BIOscience (Shenzhen) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Yaneng BIOscience (Shenzhen) Co., Ltd.
EUDAMED SRN
CN-MF-000013666
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (4)

  • EUDAMED dcdab605-728e-42f9-acb8-3ccdb4bbd547 61 fields · synced Aug 2, 2026
  • EUDAMED fc1db3c7-af3c-49ba-9ef2-5cf1f5cf1b1f 61 fields · synced May 16, 2026
  • EUDAMED 3838521d-2c6e-4c18-b22f-8f3fa5aa7f03 61 fields · synced May 17, 2026
  • EUDAMED a7dfac2b-7c68-4d6f-8baf-45695cc5caf8 61 fields · synced May 19, 2026