Eu Ivdd Eu Ivd Self Testing On The Market 🇺🇸 United States

Fortel Ultra Sensitive Pregnancy Midstream 1-Test

Biomerica, Inc. · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1

Basic Information

Primary DI
00083059114713
Basic UDI-DI Code
B-00083059114713
Reference
1147-01
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd Self Testing
Status
On The Market
Manufacturer
Biomerica, Inc.

Additional Description

Rapid test for the determination of human chorionic gonadotropin (hCG) in urine.

CND Nomenclature Codes

Code Description
W0102160302 HCG - RT & POC

Certificates

Type Number
IVDD Annex IV (excluding sections 4, 6) 20560

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