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17beta-Estradiol Saliva Luminescence Immunoassay
EUDAMEDFDA UDIClass B (EU MDR)
Ref RE62149
Identity
- Trade Name
- 17beta-Estradiol Saliva Luminescence Immunoassay EUDAMEDFDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- 17beta-Estradiol Saliva Luminescence Immunoassay EUDAMED17beta-Estradiol Saliva Luminescence Immunoassay - 10 x 96 Determinations FDA UDI
- Model / Reference
- RE62149 EUDAMEDFDA UDI
- Description
- 17beta-Estradiol Saliva Luminescence Immunoassay - 10 x 96 Determinations FDA UDI
Identifiers
- Catalog Number
- RE62149 FDA UDI
- Primary DI / UDI-DI
- 04049325030541 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049325IVR06080011BTL EUDAMED
- FDA Product Code
- CHP FDA UDI
- EMDN Code
- W0102050103 ESTRADIOL EUDAMED
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B 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
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
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 Luminescence Immunoassay by Ibl International Gmbh — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4049325IVR06080011BTL | 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 (2)
- EUDAMED bd1d6ec7-0e24-4af1-be13-fd842dfb40bf 61 fields · synced May 30, 2026
- FDA UDI 622df9da-34fb-46f2-9268-f6be75f1f5bc 36 fields · synced May 30, 2026