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BioSign hCG

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref BSP-121-35

by Princeton BioMeditech Corporation

Identity

Trade Name
BioSign® hCG card FDA UDI
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Device Name
BioSign hCG EUDAMED
BioSign® hCG card; 35 Test kit FDA UDI
Model / Reference
BSP-121-35 EUDAMED
BSP-121-35-00 FDA UDI
Description
BioSign® hCG card; 35 Test kit FDA UDI

Identifiers

Catalog Number
BSP-121-35-00 FDA UDI
Primary DI / UDI-DI
10743816000532 EUDAMEDFDA UDI
Basic UDI-DI
B-10743816000532 EUDAMED
FDA Product Code
DHA FDA UDI
EMDN Code
W0102160399 FERTILITY/PREGNANCY RT & POC - OTHER EUDAMED
GMDN Term
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.1155 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

BioSign hCG by Princeton Biomeditech Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Princeton BioMeditech Corporation
EUDAMED SRN
US-MF-000048310
Authorised Representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (2)

  • EUDAMED ad6eba35-5879-42cd-8c16-3e09ef1ddd65 61 fields · synced Jun 1, 2026
  • FDA UDI 52a00994-e2f5-49b5-afaa-c350f92f2d74 36 fields · synced May 30, 2026