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17beta-Estradiol Saliva ELISA
EUDAMEDFDA UDIClass B (EU MDR)
Ref 30121045Ref RE52041
Identity
- Trade Name
- 17beta-Estradiol Saliva ELISA EUDAMEDFDA UDI17beta-Estradiol ELISA EUDAMED
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 17beta-Estradiol Saliva ELISA EUDAMED17beta-Estradiol ELISA EUDAMED17beta-Estradiol Saliva ELISA - 96 Determinations FDA UDI
- Model / Reference
- 30121045 EUDAMEDFDA UDIRE52041 EUDAMED
- Description
- 17beta-Estradiol Saliva ELISA - 96 Determinations FDA UDI
Identifiers
- Catalog Number
- 30121045 FDA UDI
- Primary DI / UDI-DI
- 04049325030558 EUDAMEDFDA UDI04049325001664 EUDAMED
- Basic UDI-DI
- 4049325IVR06080010BTH EUDAMEDB-04049325001664 EUDAMED
- Direct Marketing DI
- 04049325030558 EUDAMED
- FDA Product Code
- CHP FDA UDI
- EMDN Code
- W0102050103 ESTRADIOL EUDAMED
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1260 FDA UDI
- Market of Registration
- Germany 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
EUDAMEDEUDAMED
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
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
17beta-Estradiol Saliva ELISA by Ibl International Gmbh — Class B — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 4049325IVR06080010BTH | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 4049325IVR06080010BTH | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- IBL International GmbH
- EUDAMED SRN
- DE-MF-000015709
Sources (3)
- EUDAMED 9b74d5d9-14ed-4f20-9a5b-d33a1d7446ef 61 fields · synced Jul 21, 2026
- FDA UDI 565e4254-fe28-4e60-be26-acd8d97ffc60 36 fields · synced May 30, 2026
- EUDAMED 64bd9d93-9804-42aa-88c0-4267e487e7fe 61 fields · synced Jul 11, 2026