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H. pylori Antigen Rapid Test

EUDAMED

Class B (EU MDR)

Ref IHP-N601B-25Ref IHP-N602B-25Ref IHP-N602-25Ref IHP-N601J-25Ref IHP-N602J-20

by Hangzhou Alltest Biotech.Co., Ltd.

Identity

Trade Name
H. pylori Antigen Rapid Test EUDAMED
Device Name
H. pylori Antigen Rapid Test EUDAMED
Model / Reference
IHP-N601B-25 EUDAMED
IHP-N602B-25 EUDAMED
IHP-N602-25 EUDAMED
IHP-N601J-25 EUDAMED
IHP-N602J-20 EUDAMED

Identifiers

Primary DI / UDI-DI
06936983115544 EUDAMED
06936983115568 EUDAMED
06936983104678 EUDAMED
06936983115919 EUDAMED
06936983115926 EUDAMED
Basic UDI-DI
6970277510000JXV EUDAMED
EMDN Code
W0105090102 H. PYLORI - RT & POC EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

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

New Device

No

EUDAMED

H. pylori Antigen Rapid Test by Hangzhou Alltest Biotech.Co., Ltd. — Class B — 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 Alltest Biotech.Co., Ltd.
EUDAMED SRN
CN-MF-000010710
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (5)

  • EUDAMED f1c4fa1d-0366-4592-94fc-3159a6faca0d 61 fields · synced Jul 20, 2026
  • EUDAMED 87a4a322-8399-4967-88e7-f5fe3305cf76 61 fields · synced May 17, 2026
  • EUDAMED 71453bcf-57fd-42a7-bace-edae0c7bd1ce 61 fields · synced May 18, 2026
  • EUDAMED 1e4d8676-9bbf-495b-9f62-cb8c06e123c3 61 fields · synced May 18, 2026
  • EUDAMED be7921df-9447-4185-9a31-88e718a51d90 61 fields · synced May 19, 2026