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Novel Coronavirus(COVID-19) Antigen Test Kit(Colloidal Gold)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 303035
Identity
- Trade Name
- femometer FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, reagent FDA UDI
- Device Name
- Novel Coronavirus(COVID-19) Antigen Test Kit(Colloidal Gold) EUDAMEDThis product is a rapid, one-step, visual test for the qualitative detection of follicle stimulating hormone (FSH) in human urine. It is intended for self-testing. It is to be used as a confirmation of body hormone changes related to the symptoms associated with the changes of menopause and as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful. FDA UDI
- Model / Reference
- 303035 EUDAMEDFM-IVY-104 FDA UDI
- Description
- This product is a rapid, one-step, visual test for the qualitative detection of follicle stimulating hormone (FSH) in human urine. It is intended for self-testing. It is to be used as a confirmation of body hormone changes related to the symptoms associated with the changes of menopause and as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972412612017 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972412612017 EUDAMED
- EMDN Code
- W010106020301 URINE SEDIMENT TEST KIT (MANUAL) EUDAMED
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Novel Coronavirus(COVID-19) Antigen Test Kit(Colloidal Gold) by Hangzhou Laihe Biotech Co., Ltd. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06972412612017 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000033566
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED be158ddd-52d7-4d90-a961-e36da61c1b14 61 fields · synced Jul 18, 2026
- FDA UDI 08ef4d59-13a6-4948-a338-c1443cd85a2a 33 fields · synced May 30, 2026